Eye Plaque Brachytherapy for Ocular Melanoma

Launched by DUKE UNIVERSITY · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called eye plaque brachytherapy for patients with a specific type of eye cancer known as ocular melanoma. The researchers want to find out if using lower doses of radiation can effectively control the cancer while causing fewer side effects. Participants will be closely monitored to see how well this approach works and how it impacts their health.

To be eligible for this study, patients need to be at least 18 years old and have a small or medium-sized melanoma in one eye, which can be treated with the plaque therapy. This means their tumor should be no taller than 10 millimeters and no wider than 16 millimeters. Additionally, patients should have good vision in the other eye and no signs of cancer spread to other parts of the body. If you join the study, you can expect regular check-ups and support from the medical team throughout the treatment process. It's important to note that those with certain types of tumors or previous cancer treatments might not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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

Trial Officials