Eye Plaque Brachytherapy for Ocular Melanoma

Ocular Melanoma Clinical Trial

— PROMPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432660
• Other study ID #: Pro00115893
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2029

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Joan Cahill, BNS RN OCN
• Phone: (919) 668-5211
• Email: Joan.Cahill[@]duke.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2029
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Ocular Melanoma

Intervention

Other:
• Data collection
Information about radiation therapy via eye plaque brachytherapy and follow up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

References & Publications (1)

Meltsner SG, Rodrigues A, Materin MA, Kirsch DG, Craciunescu O. Transitioning from a COMS-based plaque brachytherapy program to using eye physics plaques and plaque simulator treatment planning system: A single institutional experience. J Appl Clin Med Phys. 2023 May;24(5):e13902. doi: 10.1002/acm2.13902. Epub 2023 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with no disease recurrence within the radiation therapy field.	Number of disease free participants expressed as a percentage of the total number of participants enrolled	5 years