Eye Plaque Brachytherapy for Ocular Melanoma

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.

Conditions

Ocular Melanoma

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Study Overview

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Study Details

Study overview

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.

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

Eye Plaque Brachytherapy for Ocular Melanoma

Condition
Ocular Melanoma
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

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

Study Record Dates

2029-06