NCT06432660Active, not recruiting
Eye Plaque Brachytherapy for Ocular Melanoma
Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 42 (actual)
- First submitted
- 23 May 2024
- Start date
- 3 Jul 2024
- Primary completion date
- Sept 2029
- Lead sponsor
- Duke University
- Diseases
- Melanoma
- NCT number
- NCT06432660
What you commit to
- Study type: Observational
- Participants enrolled: 42
- From 3 Jul 2024 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for ocular melanoma in either eye or treatment of any condition secondary to the tumor are ineligible.
Other illness
- Patients with a history of other primary or metastatic cancers are not eligible, except for non-melanotic skin cancers
- Patients with extraocular disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.