Eye Plaque Brachytherapy for Ocular Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06432660
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Duke University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dianda Ayala-Peacock, MD
Principal Investigator Affiliation	Duke University Health System (DUHS)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ocular Melanoma

Arms & Interventions

Arms

: Ocular Melanoma

Patients 18 years of age or older with unilateral primary choroidal melanoma

Interventions

Other: - Data collection

Information about radiation therapy via eye plaque brachytherapy and follow up

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Joan Cahill, BNS RN OCN

[email protected]

(919) 668-5211

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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