Vascular Response to Brachytherapy Using Functional OCT

NCT01955941 | Completed

• 2 other identifiers: IRB00009501IRB#00009501
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.

Conditions

Uveal Melanoma

Keywords

Uveal melanoma; brachytherapy; radiation; ciliary body; choroid; I-125 plaque brachytherapy

Outcome Measures

Primary Outcomes (2)

• Blood flow pattern changes in uveal melanoma patients after radiation treatment (Cohort A)

  The purpose of this study is to learn how blood flows to tumors in important structures of the eye in patients treated with I-125 plaque brachytherapy for uveal melanoma. This will be assessed using Doppler OCT and OCT angiography technologies.

  60 months

• Blood flow pattern changes in uveal melanoma in eyes with more advanced radiation-induced changes (Cohort B)

  Describe changes over time in tumor vascularity and vascular caliber as measured by OCT angiography in eyes that have already undergone I-125 plaque therapy and demonstrate signs of radiation-induced changes.

  1 study session

Study Arms (2)

Cohort A

Patients with uveal melanoma for which brachytherapy is recommended will be considered and evaluated for enrollment into this study in order to describe the association between radiation treatment and changes in vision and blood flow within these treated eyes. Changes in vision and blood flow will be monitored at yearly intervals over a 5-year period. Up to 60 subjects will be recruited for this group.

Cohort B

Patients with uveal melanoma who have previously undergone I-125 plaque brachytherapy will be considered for enrollment into this study to evaluate blood flow in eyes with more advanced radiation-induced changes. This group will only undergo a one-time study session. Up to 40 subjects will be recruited for this group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will measure blood flow changes in 28 patients with uveal melanoma requiring radiation therapy.

You may qualify if:

• Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.

You may not qualify if:

• Inability to give informed consent.
• Inability to maintain stable fixation for OCT imaging
• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
• Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Alison Skalet, MD, PhD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)