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临床试验/NCT01955941
NCT01955941已完成不适用

Characterization of Vascular Response to Brachytherapy Using Functional Optical Coherence Tomography

OHSU Knight Cancer Institute1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
Blood flow pattern changes in uveal melanoma in eyes with more advanced radiation-induced changes (Cohort B)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 1 study session

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.

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

时间窗: 60 months

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alison Skalet

Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology

Oregon Health and Science University

研究点 (1)

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