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NCT06432660 | RECRUITING | Ocular Melanoma

Eye Plaque Brachytherapy for Ocular Melanoma
Sponsor:

Duke University

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.

Condition or disease

Ocular Melanoma

Intervention/treatment

Data collection

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Prospective Registry of Ocular Melanoma Eye Plaque brachyTherapy Patients (PROMPT)
Actual Study Start Date : 2024-07-03
Estimated Primary Completion Date : 2029-06
Estimated Study Completion Date : 2029-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Eye Plaque Brachytherapy for Ocular Melanoma

Location Details

NCT06432660

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710