Phase
Condition
Melanoma
Treatment
Data collection
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
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