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ORIGINAL ARTICLE
Year : 2021  |  Volume : 17  |  Issue : 2  |  Page : 340-347

Prostate permanent implant brachytherapy with BARC I-125 Ocu-Prosta seeds


Departments of Radiation Physics and Radiation Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India

Date of Submission09-Apr-2020
Date of Decision01-Jun-2020
Date of Acceptance10-Sep-2020
Date of Web Publication11-Jun-2021

Correspondence Address:
Sathiyan Saminathan
Department of Radiation Physics, Kidwai Memorial Institute of Oncology, Bengaluru - 560 029, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcrt.JCRT_424_20

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 > Abstract 


Aim: The aim of this study is implementation and establishment of standard operating procedure for permanent prostate implant brachytherapy technique using BARC I-125 Ocu-Prosta seeds.
Materials and Methods: The transrectal ultrasound (US)-guided procedure was used for permanent implant procedure. The Best® Sonalis™ US Imaging System and Best NOMOS™ Treatment Planning system was used for volume study and implant procedure. The BARC provided I-125 Ocu-Pro radioactive seeds were implanted into the patient with help of Mick@ Applicator. The implant was performed based on pre-implant dosimetry and intraoperative planning performed during implant procedure.
Results: The necessary quality assurance tests were performed for US system before clinical use. The boost dose of 110 Gy was prescribed to the prostate volume of 34.71 cc. About 48 seeds with activity of 0.35 mCi (each) implanted into the prostate volume with reference to intraoperative planning. At the end of procedure, the patient underwent abdomen fluoroscopic examination, to ensure the seed counts in the prostate volume. The day after the implant, the patient was discharged. One month later a planning computed tomography and treatment planning was performed for seed position and dose verification.
Conclusions: Low dose rate permanent implant brachytherapy has the advantage of being a one-time procedure and the existing long term follow-up supports its excellent outcome and low morbidity. BARC-BRIT is supplying the loose 125I seeds. These seeds can be easily implanted into the patient using Mick applicator. However, the pre-implant seed preparation and implant procedure may result some radiation exposure to staff involved. The radiation dose can be minimized with good practice. This report is one patient pilot study and intended to test the implant systems and standard operative procedure henceforth for permanent implant brachytherapy procedure.

Keywords: Dosimetry, I-125 seed, permanent implant bracytherapy, prostate


How to cite this article:
Palled SR, Saminathan S, Pasha T, Naveen T, Ganesh K M, Lokesh V. Prostate permanent implant brachytherapy with BARC I-125 Ocu-Prosta seeds. J Can Res Ther 2021;17:340-7

How to cite this URL:
Palled SR, Saminathan S, Pasha T, Naveen T, Ganesh K M, Lokesh V. Prostate permanent implant brachytherapy with BARC I-125 Ocu-Prosta seeds. J Can Res Ther [serial online] 2021 [cited 2021 Sep 23];17:340-7. Available from: https://www.cancerjournal.net/text.asp?2021/17/2/340/318110




 > Introduction Top


Prostate cancer is one among the top 10 leading cancers in India. It usually affects men in the age group of 65+ years. However, recently, there has been reports indicating an increase in the incidence of cancer in younger men in the age group of 35–44 and 55–64 years residing in the metropolitan cities.[1] Old age, obesity, improper diet, and genetic alterations have been identified as some of the main contributing factors toward an increased cause of prostate cancer. The 5-year survival rate for prostate cancer in India is 64%. Researchers are of the belief that the incidence of prostate cancer is likely to double by 2025. As per the Indian Medical Council Research, prostate cancer is the second leading cancer among males in cities such as Pune, Kolkata, Delhi, and Thiruvananthapuram. It is the third leading cancer in cities such as Mumbai and Bengaluru.[2]

Permanent seed implant alone is performed in very low risk cases and as adjuvant to external-beam radiotherapy (EBRT) in intermediate and high risk cases.[3] Permanent low dose rate (LDR) implant is performed as free-hand procedure or more recent real time transrectal ultrasound (TRUS)-guided focal LDR brachytherapy. Whitmore et al. were mentioned that the seed implantation was performed as free-hand seeds placement in an open surgical procedure through the retropubic approach.[4] The open surgical technique was suffered from substantial uncertainties in dosimetric planning, implant execution, and dose evaluation. Now-a-days, seed implantation is performed under template and TRUS guidance. TRUS-guided permanent prostate implant provides the three dimensional (3D) anatomy-based dosimetric planning, real-time diagnostic imaging guidance, and fast dose fall-off due to lower energy radionuclides. Although the permanent prostate implant technique is well-established in Europe and United States, it is not an established technique in our country. This article describes the implementation and establishment SOP for permanent prostate implant technique in our center.


 > Materials and Methods Top


The manual after loading permanent implant brachytherapy technique was started in our centre with the required regulatory approval. The low-energy iodine-125 radioactive seed used for permanent implant is having the average photon energy 28.5 KeV. The specific gamma-ray constant is 1.45 R· cm2/mCi·h, and half-life is 59.4 days. The 10-mm concrete thickness is more than adequate for room shielding (concrete TVL = 7.3 mm for I-125 source). However, the normal operation theater (OT) is having the wall thickness of 150 mm concrete, which is more than adequate room shielding for the I-125 low energy radioactive source used in our center. The OT and other facilities pertaining to permanent implant facility should be isolated from other routine activities. In addition to OT, other facilitates such as source storage room, patient recover room, and nursing station are mandatory for manual after loading permanent implant Brachytherapy layout plan.

Ultrasound imaging system

The Best® Sonalis™ ultrasound (US) imaging is a computer-based system. The transducer probe has three sets of array, two for sagittal and one for transverse imaging. The SimulView technology of a two-dimensional array provides the simultaneous imaging of transverse and sagittal planes. Longitudinal array provides for 140-mm length of view at maximum depth, encompassing the bladder, prostate, and perineum.

Quality assurance of ultrasound system

The quality assurance (QA) of US system includes acceptance testing and periodic tests. The US prostate phantom [Figure 1] is a multi-modality disposable phantom useful for practicing procedures which involve scanning the prostate with a rectal probe. The prostate along with structures simulating the rectal wall, seminal vesicles, and urethra is contained in the phantom. This phantom is an ideal training device for US-guided cryosurgery, radioactive seed implantation, and needle biopsy.
Figure 1: Ultrasound prostate phantom

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The Brachytherapy QA phantom was used to commission the US system. The phantom is made of hydrogel polymer having the design as specified in the AAPM TG 128 recommendation.[5] [Figure 2]a and [Figure 2]b shows the phantom and cross-section views. It consists of three target volumes 4 cc, 9 cc, and 20 cc. The 'N' shape internal grid having 13 target points, six probe retraction grids (three with 5 mm spacing and another three with 10 mm spacing).
Figure 2: (a) Brachytherapy quality assurance phantom. (b) Cross section view of brachytherapy quality assurance phantom

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The electronic grid generated by the US system provides a reference for needle locations in the treatment plan system. It is important to verify that the electronic grid overlay matches the location of the actual needle template. If this alignment is not correct, needles cannot be physically inserted according to the preplan. The stepper is positioned in the vertical direction, the probe assembly and needle template was completely immersed in water. One needle at center and another four needles at each corner were placed in the needle template to check the positional accuracy.

Needle template and electronic grid alignment

The electronic grid generated by the US system provides a reference for needle locations in the treatment plan system. For preplanning procedure, the actual needle template should match with the US and TPS electronic grid. If this alignment is not correct, needles cannot be physically inserted according to the preplan.

Treatment planning system

The Best® NOMOS (DBA: Best Medical International, Inc., Pittsburgh, PA, USA), treatment planning systems (TPS) dual activity module creates the treatment plans using multiple activity sources. Octant Therapy™ Module allows view of DVH values of specific prostate volumes. Slice Shifter™ provides ability to correct image slice-positioning errors. The concurrent 2D and 3D visualization allows instant visualization of seed placement, dose distribution, and anatomical structures. The pattern loading feature can be used for new plans with user definable seed pattern loading. This TPS supports both the volume plan (version 4.9n) and CT plan (version 4.01). In volume plan, we can perform the PrePlan or operating room (OR) dosimetry. The TPS can be connected to US unit to access the live video image. From the live video, the images can be acquired to TPS with set of Z-values for PrePlan dosimetry. The real-time planning is not possible with this TPS. However, in the operation room (OR), the intraoperative planning can be performed known as real-time planning. The patient remains stationary between the time of the volume study and the implant procedure. The postimplant CT provides the post plan dosimetry with the help of auto seed detection method.

Volume plan procedure

The images can be captured from US system to TPS and template will be registered as explained earlier. The contouring of target and organs at risk (OAR) and dose prescription is performed by the radiation oncologist. The seeds can be selected from the seed library. The seed and needle loading can be performed using alternative seed pattern mode or geometric loading or inverse planning. The DVH analysis provides the information about volume and dose. The seed loading spreadsheet provides the information about needle and seed location for both mick and pre-loaded applicators.

Computed tomography plan procedure

The postimplant CT images can be loaded into TPS and grids aligned for the auto seed selection procedure. The contouring of target and OAR will be drawn on CT images. The seed selection mode detects the correct location of implanted seeds. Any alternation in the seed location can be corrected by adding or deleting the seeds. The postimplant volume and dose can be accessed from the DVH analysis.

Stepper/stabilizer

Best® Stepper/stabilizers patented cradle design provides the absolute calibration of the transverse US image. The finite travel in all six axes allows for smooth, one-handed positioning without requiring fine adjustments. The mounts are provided for standard rail dimensions and multiple table width [Figure 3].
Figure 3: Stepper and stabilizer

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Applicators for seed loading

The pre-loaded needles with active seed and spacers based on pre-plan dosimetry are available by different vendors. These seeds can be directly loaded into the prostate volume with template and needle guidance. The vendors are also supplying the loose seeds, this can be loaded onto the patient using Mick@ (Eckert and Ziegler BEBIG, Germany) or seed Selectron@ (Elekta) or Quicklink@ (Bard) cartridges and applicators.[6] We used the loose seeds; this can be loaded to the patient using Mick@ applicator. Mick TPV applicator was attached to the implanted Mick® TP Needle, the applicator assembly allows the seeds to be inserted individually as per pre-plan or real-time dosimetry. The applicator allows for instantaneous seed spacing selections of positions neutral (N), 3.75 mm, 4.0 mm, 5.0 mm, 5.5 mm, and 6.0 mm. The neutral position disengages the clicking mechanism to prevent needle displacement while resetting the template ring. The Mick magazines are designed for use of I-125 or pd-103 seeds. When the seeds are loaded they held captive thus eliminating the loss of seeds during the handling and sterilization process. Disposable Mick® Magazines for single use and they can be autoclaved for one sterilization cycle. The capacity per magazine is 15 or 20 seeds. The capacity per magazine is 10 seeds for reusable Mick® Magazines [Figure 4].
Figure 4: Mick applicator and magazines

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Patient selection

The prostate cancer Patient for Radiotherapy are usually those, who cannot undergo surgery, older than 65 years or with locally advanced disease, for example, extracapsular spread.[7] The European Association of Urology recommends the monotherapy treatment of transperineal bracytherapy for clinical stage between T1c and T2a, without nodal involvement or metastases.[8] American Brachytherapy Society also recommended that the LDR brachytherapy (LDR-BT) alone should be done in low-risk patients and an option for intermediate group. EBRT and permanent seed combination is considered as standard of care for high risk patients.[9] The ideal volume of prostate for permanent implant is 20–50 cm3 and the patients with pre-brachytherapy posttransurethral resection of the prostate (TRUP) are not suitable of brachytherapy.[10] The high risk patient was selected in our study based on literature recommendation.

Preimplant dosimetry

To acquire the US image for per plan dosimetry, the stepper, template, and US probe were fixed in the OT table along with patient. The US unit was connected to the TPS, and images were acquired at 5 mm interval by fixing the Z-value. The image template was registered with the TPS template. The activity and the number of radioactive I-125 seeds required for the implant were decided from the preplan volume images. The order was placed with the vendor to procure the radioactive seeds. By considering the edema and delay in supply, additional ten seeds were ordered along with actual the required number of seeds. The preplan volume study was performed 3–4 weeks before the implant date. The dose prescription to the target volume and dose to organ at risk were recommended in the literature for permanent implant procedure with I-125 seed source,[7],[11] [Table 1] shows the literature recommended dose values and doses to OAR.
Table 1: Dose recommendation and dose constrains for I-125 permanent implant brachytherapy

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Radioactive seeds

The BARC I-125 Ocu-Pro seed consists of 0.5 mm diameter and 3.0 mm long silver rod coated with palladium and on which I125 is absorbed. It is encapsulated in a hollow cylindrical titanium tube of 0.05 mm thick wall. The external dimensions of the seed are 0.8 mm diameter and 4.75 mm length. The cap end of the cylinder is sealed by laser welding.[12],[13] Details about the fabrication of this source are given in the literature[14],[15],[16] [Figure 5].
Figure 5: Cross section of the source

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Preimplant seed preparation

The loose seeds were received in the shielded transport container. The well chamber was used to the check source strength. The calibration of low-energy LDR source is the responsibility of hospital physicist.[6],[17] In each cartridge, around ten seeds were loaded, and the cartridges were loaded in to shielding container [Figure 6]. The entire operation was performed behind the L-bench. The seeds loaded cartridges were sterilized in an autoclave. The autoclave cycle was 120°C at 15 PSI for about 30 min.[18] A Geiger–Muller (GM) Counter and pocket dosimeter were used during the seed preparation to account the radiation exposure.
Figure 6: Cartridge and transport container

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Treatment planning system configuration with BARC I-125 Ocu-Pro seed

The point-source approximation is used in Best® NOMOS permanent implant TPS.[19] The BARC I-125 Ocu-Pro seeds were configured in the dose kernel model of the TPS with the source physical properties of source strength, length, half-life, air kerma rate constant, and dose rate constant. The dose kernel model was verified with literature data.[16] The BARC I-125 Ocu-Pro seed were configured for both PrePlan and post plan CT dosimetry.

Implant procedure

After taking written consent, patient was taken up for the procedure. The patient was positioned in extended dorsolithotomy position in the OT table under spinal anesthesia. Draped with sterile cover, Perineum was cleaned with betadine, and scrotum was retracted. The bladder was catheterized. The stepper, template, and US probe were fixed. The US gel was used to main the good acoustic coupling between transrectal probe and rectum. On the day of implant, the position of the prostate was maintained to reproduce the position as done at the time of volume study. In order to create the intraoperative planning (final plan was created just before the implant), the US unit was connected to the TPS and images were acquired at 5 mm interval by fixing the Z-value.

Radiation safety during implant procedure

All the workers involved in the implant procedure were provided with personnel monitoring badge (TLD) and pocket dosimeter. The individual's accumulated dose for entire procedure was recorded in both dosimeters. The shielding container was used to carry the sources from the source storage room to OT room.


 > Results and Discussion Top


LDR permanent implant brachytherapy has the advantage of being a one-time procedure and the existing long-term follow-up supports its excellent outcome and low morbidity. External-beam therapy treatment alone requires 6–7 weeks of treatment. The target conformity and OAR sparing will be better in LDR permanent implant brachytherapy for low risk prostate patients compared to other treatment modalities. The posttreatment quantitative dosimetry is not possible with HDR treatment modality.

The seed implant provides superior prostate-specific antigen (PSA)-free survival in low risk patients.[7] Brachytherapy seems to be superior option for dose escalation and PSA control in prostate cancer patients. The LDR brachytherapy can be used as monotherapy, whereas HDR treatment to be combined with EBRT. The average biologically effective dose (BEffD) and equivalent dose (Deq), were similar with HDR-BT and LDR-BT using I-125 permanent radioactive seeds. The rectal and urethral irradiated volumes were slightly smaller with LDR-bracytherapy. Dose-volume distribution of LDR-BT in the rectum appeared to be more inhomogeneous compared to other techniques.[20] The dose to urethra can be minimized in permanent implant brachytherapy treatment.

The dose distributions following implantation are not the same as those planned prior to the implant, because the dose distributions differ, it is important to document the actual dose that the prostate and normal adjacent tissues will receive over the life of the implant. This can only be determined if a post implant dosimetric (PID) assessment is performed. Significant under dosing of the prostate can lead to treatment failure, this can be potentially rectified using supplemental external-beam irradiation or additional seed implantation.[21] Marcu and Quach stated that there is a large variations in postimplant dosimetric parameters compared to the preimplant data. The quality of an implant can be assessed by effectuating postimplant dosimetry. Postimplant dosimetry could be increased by developing in-house guidelines.[22] Marcu et al. stated that the CT-based PID was found to be less reliable than US-CT fusion-based PID due to target overestimation.[23]

AAPM TG 137 report[16] address the issues related LDR prostate permanent implant brachytherapy.

Quality assurance of ultrasound system

The multi-modality prostate phantom is useful tool for permanent implant procedure practice. The organ of interest can be contoured in the US image. The US image of phantom is shown in [Figure 7]. The Brachytherapy QA phantom was used for the volume and distance measurements in US image. The measurement values are within the acceptable limit with reference to actual values in the Brachytherapy QA phantom shown in [Table 2].
Figure 7: Ultrasound image of prostate phantom

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Table 2: Comparison of actual and measured values in brachytherapy quality assurance phantom

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The locations of the needles were verified in the US image with respect to actual template and needle position. The inaccuracy was corrected by adjusting the needle and template position. The accepted tolerance was within 3 mm. The actual template and needle positions are verified with reference to electronic grid in US image. The miss-alignment was corrected by adjusting the template and needle positions.

Implant procedure

The US images were acquired from cranio-caudal direction at 5 mm interval by fixing the Z-value, just before the implant. The sagittal section on the prostate US image can be used as an extra guidance for seed placement. Our US system provides both sagittal and axial section images simultaneously. The US images were transferred to the TPS. The electronic grid of US system was aligned with the TPS grid. The prostate, urethra and rectum were contoured. We prescribed 110 Gy to prostate volume with permanent implant later 50.4 Gy was delivered with EBRT boost dose as recommended by Piotr Wojcieszek and Białas.[7] The proper needle seed positions were selected to get the adequate dose coverage to prostate volume. About 48 seeds (activity of 0.35 mCi per seed) were used to deliver a dose of 102.5 Gy (at D90) to the prostate volume of 34.71 cc. The V150 of urethra was received almost nil doses. The maximum dose for rectum was 79%. We took at most care to avoid seeds in urethra and minimized the less number of needles to implant volume.

The final plan was accepted and OR worksheet, seed loading spreadsheet was kept ready for implant procedure. These give the information about needle and seed position in the template. The needle with stylet was inserted in designated location through template. The stylet was removed and the needle was connected to the Mick applicator. The seed loaded cartridge was loaded in the mick applicator. The radioactive seeds were dropped in the pre-planned location by selecting the seed spacing selection in the mick applicator under the US imaging. During the procedure the needle and seed positions were double checked to avoid the wrong seed insertion. At the end of procedure the patient underwent abdomen fluoroscopic examination, to ensure the seed counts in prostate volume. The day after the implant, the patient was discharged and one month later a planning CT and treatment planning was performed for seed position and dose verification. In the post implant dosimetry, the calculated D90 to prostate volume was 70 Gy and D2cc of bladder was 62 Gy and rectum was 64 Gy respectively. The dose correction to low dose volume was carried out in EBRT.

Radiation safety during implant procedure

To maintain the safety procedure and workflow the check list was maintained for the implant procedure. [Table 3] shows the permanent implant procedure check list. Each needle was surveyed after withdrawn from the patient to check for any seed struck in the used needle. All the workers involved in the implant procedure were provided with personnel monitoring badge (TLD) and pocket dosimeter. The personnel monitoring badge gives accumulated dose for 3 months. The dose report of the personnel monitoring badge (TLD badge) was the zero to all radiation workers. The pocket dosimeter gives individual's accumulated dose during the procedure. The maximum recorded individual dose was 115 μR/hr. After the implant procedure, the exposure rate at the surface of the patient was 200 μR/h and 50 μR/h at 1 m distance from the patient. A complete radiation survey is conducted to the vicinity of implant area, the floor, wastes, linen and all used applicator. The used and unused seed counts were taken into account. The unused seeds were returned to the shielding safe, which will be sent back to the supplier for safe disposal at a later date.
Table 3: Permanent implant check list

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 > Conclusions Top


The prostate permanent implant with BARC-BRIT loose 125I Ocu-prost seed is feasible. These seeds can be easily implanted into the patient using Mick applicator with TRUS guidance as a pre-planned procedure. However, the preimplant seed preparation and implant procedure may result in some radiation exposure to staff involved. The radiation dose can be minimized with good practice. The procedures followed in this article may be helpful for practicing brachytherapist in our county.

Acknowledgment

The authors would like to thank Radiopharmaceuticals Division, Bhabha Atomic Research Centre, Mumbai for providing the BARC OcuProsta I-125 seed source. A special thanks to Dr. Sanjay Kumar Saxena, Scientific Officer (F) and Dr. Ashutish Dash, Head, RPhD for their constant support and encouragement.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 > References Top

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Hariharan K, Padmanabha V. Demography and disease characteristics of prostate cancer in India. Indian J Urol 2016;32:103-8.  Back to cited text no. 1
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Pfeiffer D, Sutlief S, Feng W, Pierce HM, Kofler J. AAPM task group 128: Quality assurance tests for prostate brachytherapy ultrasound systems. Med Phys 2008;35:5471-89.  Back to cited text no. 5
    
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Perez-Calatayud J, Ballester F, Carlsson Tedgren Å, Rijnders A, Rivard MJ, Andrássy M, et al. GEC-ESTRO ACROP recommendations on calibration and traceability of LE-LDR photon-emitting brachytherapy sources at the hospital level. Radiother Oncol 2019;135:120-9.  Back to cited text no. 6
    
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Wojcieszek P, Białas B. Prostate cancer brachytherapy: Guidelines overview. J Contemp Brachytherapy 2012;4:116-20.  Back to cited text no. 7
    
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EAU. Guidelines on Prostate Cancer (2012). The Netherlands: European Association of Urology; 2012.  Back to cited text no. 8
    
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Davis BJ, Horwitz EM, Lee WR, Crook JM, Stock RG, Merrick GS, et al. American Brachytherapy Society consensus guidelines for transrectal ultrasound-guided permanent prostate brachytherapy. Brachytherapy 2012;11:6-19.  Back to cited text no. 9
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7]
 
 
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  [Table 1], [Table 2], [Table 3]



 

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