Eye Plaque Brachytherapy for Ocular Melanoma
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.
Conditions:
🦠 Ocular Melanoma
🗓️ Study Start (Actual) 3 July 2024
🗓️ Primary Completion (Estimated) June 2029
✅ Study Completion (Estimated) June 2029
👥 Enrollment (Estimated) 40
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients 18 years of age or older with unilateral primary choroidal melanoma
    • * 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)
    • * Patients with no clinical evidence of metastatic disease as confirmed by negative staging imaging (CT, MRI, and/or ultrasound)
    • * Patients with best-corrected visual acuity in the fellow eye of 20/200 or better
    • * Patients must be treated with IsoAid Eye Physics eye plaques

    Exclusion Criteria:

    • * Patients whose tumors are circumferential around the optic disc and cannot be adequately covered by the prescription dose are ineligible.
    • * 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
    • * Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
    • * Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
    • * Patients with extraocular disease
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 May 2024
  • First Submitted that Met QC Criteria 23 May 2024
  • First Posted 29 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024