RECRUITING

Eye Plaque Brachytherapy for Ocular Melanoma

Conditions

Ocular Melanoma eye plaque brachytherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)

Quick Facts

Study Start:2024-07-03

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06432660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Joan Cahill, BNS RN OCN

CONTACT

(919) 668-5211

Joan.Cahill@duke.edu

Principal Investigator

Dianda Ayala-Peacock, MD

PRINCIPAL_INVESTIGATOR

Duke University Health System (DUHS)

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Dianda Ayala-Peacock, MD, PRINCIPAL_INVESTIGATOR, Duke University Health System (DUHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03

Study Completion Date2029-06

Study Record Updates

Study Start Date2024-07-03

Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

eye plaque brachytherapy

Additional Relevant MeSH Terms

Ocular Melanoma