Vascular Response to Brachytherapy Using Functional OCT

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01955941
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

OHSU Knight Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alison Skalet, MD, PhD
Principal Investigator Affiliation OHSU Knight Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Uveal Melanoma
Additional Details

Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies:

  • (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy.
The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment. In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OHSU Knight Cancer Institute, Portland, Oregon

Status

Recruiting

Address

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Site Contact

Denny Romfh

romfhd@ohsu.edu

503-494-4351

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