Clinical trial NCT06432660: Eye Plaque Brachytherapy for Ocular Melanoma
Official title: Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ocular Melanoma
Keywords: eye plaque brachytherapy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult patients seen at the Duke Eye Center and/or Duke Department of Radiation Oncology who meet the eligibility criteria.

Brief summary: 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.


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

Primary outcomes:
measure: Percentage of participants with no disease recurrence within the radiation therapy field.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Health System (DUHS)
name: Dianda Ayala-Peacock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13.