Eye Plaque Brachytherapy for Ocular Melanoma (PROMPT)

Duke University

Status

Enrolling

Conditions

Ocular Melanoma

Treatments

Other: Data collection

Study type

Observational

Funder types

Other

Identifiers

NCT06432660

Pro00115893

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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