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OpenTrials
Active, Not Recruiting

NCT Number: NCT06432660

Eye Plaque Brachytherapy for Ocular Melanoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Information about radiation therapy via eye plaque brachytherapy and follow up

Primary outcomes

  1. Percentage of participants with no disease recurrence within the radiation therapy field.

    Time frame: 5 years

    Number of disease free participants expressed as a percentage of the total number of participants enrolled

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: PROMPT

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 29, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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