Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-27 @ 8:09 PM
Study NCT ID:
NCT06964412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Artificial Intelligence Generated Contours in Radiation Planning of the Prostate Brachytherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001185', 'term': 'Artificial Intelligence'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-21', 'size': 475749, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-01T09:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The experienced clinician will be blinded to the randomization of the contouring method by the new learner. The prostate contour generated by the new learner will then undergo review by the experienced clinician.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically approved contour vs. Manual and AI assisted contours', 'timeFrame': '1 day', 'description': 'Dice coefficient \\[0: no match, 1: complete match\\] between the final clinically approved brachytherapy prostate contours versus the manual and AI-assisted contours provided by the new learner.'}], 'secondaryOutcomes': [{'measure': 'Contouring time', 'timeFrame': '1 day', 'description': 'Contouring time-to-completion needed to generate and edit manual vs AI-assisted contours for a new learner.'}, {'measure': 'Impression of AI or manual contours by new learner', 'timeFrame': '1 day', 'description': 'Subjective impressions/perception of AI or manual contours by the new learner based on survey responses.'}, {'measure': 'Impression of AI or manual contours by experienced clinician', 'timeFrame': '1 day', 'description': 'Subjective impressions/perception of AI or manual contours by the experienced clinician based on survey responses.'}, {'measure': 'Clinician contours vs. Trus images with and without needles', 'timeFrame': '1 day', 'description': 'Dice coefficients of expert clinician contours between TRUS images with implanted needles and TRUS images after removal of bottom needle rows.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '32146259', 'type': 'BACKGROUND', 'citation': 'Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.'}, {'pmid': '31727300', 'type': 'BACKGROUND', 'citation': 'Crook J, Marban M, Batchelar D. HDR Prostate Brachytherapy. Semin Radiat Oncol. 2020 Jan;30(1):49-60. doi: 10.1016/j.semradonc.2019.08.003.'}, {'pmid': '23474112', 'type': 'BACKGROUND', 'citation': 'Chen CP, Weinberg V, Shinohara K, Roach M 3rd, Nash M, Gottschalk A, Chang AJ, Hsu IC. Salvage HDR brachytherapy for recurrent prostate cancer after previous definitive radiation therapy: 5-year outcomes. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):324-9. doi: 10.1016/j.ijrobp.2013.01.027. Epub 2013 Mar 6.'}, {'pmid': '33309278', 'type': 'BACKGROUND', 'citation': 'Valle LF, Lehrer EJ, Markovic D, Elashoff D, Levin-Epstein R, Karnes RJ, Reiter RE, Rettig M, Calais J, Nickols NG, Dess RT, Spratt DE, Steinberg ML, Nguyen PL, Davis BJ, Zaorsky NG, Kishan AU. A Systematic Review and Meta-analysis of Local Salvage Therapies After Radiotherapy for Prostate Cancer (MASTER). Eur Urol. 2021 Sep;80(3):280-292. doi: 10.1016/j.eururo.2020.11.010. Epub 2020 Dec 11.'}, {'pmid': '35233228', 'type': 'BACKGROUND', 'citation': 'Lavoie-Gagnon H, Martin AG, Poulin E, Archambault L, Pilote L, Foster W, Vigneault E, Carignan D, Lacroix F. Advantages of TRUS-based delineation for high-dose-rate prostate brachytherapy planning. J Contemp Brachytherapy. 2022 Feb;14(1):1-6. doi: 10.5114/jcb.2022.113544. Epub 2022 Feb 18.'}, {'pmid': '37316376', 'type': 'BACKGROUND', 'citation': 'Podgorsak AR, Venkatesulu BP, Abuhamad M, Harkenrider MM, Solanki AA, Roeske JC, Kang H. Dosimetric and workflow impact of synthetic-MRI use in prostate high-dose-rate brachytherapy. Brachytherapy. 2023 Sep-Oct;22(5):686-696. doi: 10.1016/j.brachy.2023.05.005. Epub 2023 Jun 12.'}, {'pmid': '37665729', 'type': 'BACKGROUND', 'citation': 'King MT, Kehayias CE, Chaunzwa T, Rosen DB, Mahal AR, Wallburn TD, Milligan MG, Dyer MA, Nguyen PL, Orio PF, Harris TC, Buzurovic I, Guthier CV. Observer preference of artificial intelligence-generated versus clinical prostate contours for ultrasound-based high dose rate brachytherapy. Med Phys. 2023 Oct;50(10):5935-5943. doi: 10.1002/mp.16716. Epub 2023 Sep 4.'}, {'pmid': '24454995', 'type': 'BACKGROUND', 'citation': 'Sullivan GM, Artino AR Jr. Analyzing and interpreting data from likert-type scales. J Grad Med Educ. 2013 Dec;5(4):541-2. doi: 10.4300/JGME-5-4-18. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html', 'label': 'American Cancer Society key statistics for prostate cancer.'}, {'url': 'https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf', 'label': 'National Comprehensive Cancer Network.'}]}, 'descriptionModule': {'briefSummary': 'This study is investigating how AI can help doctors outline the prostate on an ultrasound image to make a custom radiation plan during a specialized type of radiation treatment for prostate cancer called brachytherapy.', 'detailedDescription': 'This is a Phase II prospective study evaluating the standard U-net, a deep learning AI algorithm for auto-contouring of the prostate during HDR prostate brachytherapy with the needles in place by new learners. Contouring will be done on TRUS. The study will be conducted with a randomized design. Each patient will be assigned to a new learner and then randomized to manual versus AI-assisted contouring. The randomization will be stratified by new learner type: resident versus fellow/new attending. The hypothesis is that AI-assisted learner contours will have improved Dice coefficients with respect to clinically approved contours compared with manual learner contours. All brachytherapy contours will undergo review by the treating radiation oncologist who is the experienced clinician for clinical approval prior to patient treatment. The experienced clinician will be blinded to the randomization.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Deemed suitable candidates for whole gland HDR prostate brachytherapy under general anesthesia as a monotherapy, boost or salvage treatment.\n\nExclusion Criteria:\n\n* Prior permanent seed LDR brachytherapy implant\n* Prior transurethral resection of the prostate (TURP)\n* Presence or insertion of a rectal spacer\n* Focal HDR brachytherapy treatment i.e. not whole prostate'}, 'identificationModule': {'nctId': 'NCT06964412', 'briefTitle': 'The Use of Artificial Intelligence Generated Contours in Radiation Planning of the Prostate Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy', 'orgStudyIdInfo': {'id': '25-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'MANUALLY GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAP', 'description': 'Manual prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.'}, {'type': 'EXPERIMENTAL', 'label': 'AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY', 'description': 'AI-assisted (U-net algorithm) prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.', 'interventionNames': ['Other: Artificial-intelligence (AI)']}], 'interventions': [{'name': 'Artificial-intelligence (AI)', 'type': 'OTHER', 'description': 'Utilizing the addition of artificial intelligence during prostate contouring.', 'armGroupLabels': ['AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jaime Vladimir Mendoza, BA', 'role': 'CONTACT', 'email': 'jvladimir@bwh.harvard.edu', 'phone': '617 401 1287'}, {'name': 'Nataliya Moldovan, MD', 'role': 'CONTACT', 'email': 'nmoldovan@bwh.harvard.edu', 'phone': '617 732 4332'}], 'overallOfficials': [{'name': 'Martin King, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dana-Farber Cancer Institute / Brigham Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin King, MD, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Radiation oncologist', 'investigatorFullName': 'Martin King, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}