Vascular Response to Brachytherapy Using Functional OCT
Status: | Active, not recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | October 2013 |
End Date: | December 2022 |
Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography
The purpose of this study is to learn how blood flows to tumors in patients treated with
I-125 plaque brachytherapy for uveal melanoma.
I-125 plaque brachytherapy for uveal melanoma.
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.
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.
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.
We found this trial at
1
site
3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-7999
Phone: 503-494-4351
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