Eye Plaque Brachytherapy for Ocular Melanoma

Last updated: July 16, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Treatment

Data collection

Clinical Study ID

NCT06432660
Pro00115893
  • Ages > 18
  • All Genders

Study 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

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 plaquebrachytherapy (as determined by treating ocular oncologist). Typically this wouldinclude tumors with apical height ≤10mm and basal diameter ≤16mm (small and mediumtumors per COMS (Collaborative Ocular Melanoma Study)

  • Patients with no clinical evidence of metastatic disease as confirmed by negativestaging 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

Exclusion Criteria:

  • Patients whose tumors are circumferential around the optic disc and cannot beadequately covered by the prescription dose are ineligible.

  • Similarly, patients with extrascleral tumor extension detected during echography orclinical exam, diffuse, ring or multifocal tumors that cannot be encompassed in asingle episcleral plaque or tumors judged to be predominantly ciliary body or irismelanoma will be considered ineligible

  • Previous treatment for ocular melanoma in either eye or treatment of any conditionsecondary 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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
July 03, 2024
Estimated Completion Date:
June 30, 2029

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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