Evaluating eye plaque brachytherapy for treating ocular melanoma
Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
Duke University · NCT06432660
This study is testing if using lower doses of radiation in eye plaque therapy can effectively treat small to medium choroidal melanomas while causing fewer side effects for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06432660 on ClinicalTrials.gov |
What this trial studies
This prospective registry study aims to assess the radiation doses used in eye plaque brachytherapy for ocular melanoma and their associated outcomes. The focus is on determining whether lower doses of radiation can achieve high local control rates while reducing the side effects related to radiation therapy. Patients with small to medium choroidal melanomas will be monitored to gather data on treatment effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral primary choroidal melanoma that is small or medium in size and suitable for plaque brachytherapy.
Not a fit: Patients with tumors that cannot be adequately treated with the prescribed dose or those with metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that minimize radiation toxicity while maintaining effective control of ocular melanoma.
How similar studies have performed: Other studies have explored brachytherapy for ocular melanoma, but this specific approach focusing on lower radiation doses is relatively novel.
Eligibility criteria
Show full 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
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Dianda Ayala-Peacock, MD — Duke University Health System (DUHS)
- Study coordinator: Kaitlin Bailey, BNS RN OCN
- Email: Kaitlin.Bailey@duke.edu
- Phone: (919) 668-3726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ocular Melanoma, eye plaque brachytherapy