Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-04-10 @ 12:18 AM
Study NCT ID:
NCT06432660
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eye Plaque Brachytherapy for Ocular Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with no disease recurrence within the radiation therapy field.', 'timeFrame': '5 years', 'description': 'Number of disease free participants expressed as a percentage of the total number of participants enrolled'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eye plaque brachytherapy'], 'conditions': ['Ocular Melanoma']}, 'referencesModule': {'references': [{'pmid': '36637797', 'type': 'BACKGROUND', 'citation': 'Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'This prospective registry study will evaluate doses utilized in eye plaque brachytherapy for the treatment of ocular melanoma and their associated outcomes. The goal of this study is to evaluate if lower doses of radiation can maintain high local control rates while minimizing the toxicities related to radiation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adult patients seen at the Duke Eye Center and/or Duke Department of Radiation Oncology who meet the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older with unilateral primary choroidal melanoma\n* Patients with diagnosis of small or medium ocular melanomas amenable to plaque brachytherapy (as determined by treating ocular oncologist). Typically this would include tumors with apical height ≤10mm and basal diameter ≤16mm (small and medium tumors per COMS (Collaborative Ocular Melanoma Study)\n* Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)\n* Patients with best-corrected visual acuity in the fellow eye of 20/200 or better\n* Patients must be treated with IsoAid Eye Physics eye plaques\n\nExclusion Criteria:\n\n* Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.\n* Similarly, patients with extrascleral tumor extension detected during echography or clinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in a single episcleral plaque or tumors judged to be predominantly ciliary body or iris melanoma will be considered ineligible\n* Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.\n* Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers\n* Patients with extraocular disease'}, 'identificationModule': {'nctId': 'NCT06432660', 'acronym': 'PROMPT', 'briefTitle': 'Eye Plaque Brachytherapy for Ocular Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)', 'orgStudyIdInfo': {'id': 'Pro00115893'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ocular Melanoma', 'description': 'Patients 18 years of age or older with unilateral primary choroidal melanoma', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Information about radiation therapy via eye plaque brachytherapy and follow up', 'armGroupLabels': ['Ocular Melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office', 'role': 'CONTACT', 'phone': '919-668-3726'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Kaitlin Bailey, BNS RN OCN', 'role': 'CONTACT', 'email': 'Kaitlin.Bailey@duke.edu', 'phone': '(919) 668-3726'}], 'overallOfficials': [{'name': 'Dianda Ayala-Peacock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Health System (DUHS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}