Eye Plaque Brachytherapy for Ocular Melanoma
Running, not enrolling
Conditions studied: Ocular Melanoma
In brief
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.
Key facts
- Study ID
- NCT06432660
- Run by
- Duke University
- People needed
- 42
- Starts
- 2024-07-03
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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