- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01955915
Blood Vessel Patterns in Small Choroidal Tumors
Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography
Study Overview
Status
Conditions
Detailed Description
Uveal melanomas are melanocytic tumors that arise in the pigmented tissues of the eye: the iris, ciliary body, and choroid. Iris melanomas rarely metastasize (spread to other tissues or organs). In contrast, uveal melanomas arising in the ciliary body and choroid are highly malignant (cancerous and invasive to other tissues or organs). 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. Therefore patients diagnosed with uveal melanoma must cope with not only a life-threatening illness, but also the frightening prospect of significant vision loss. Choroidal melanomas located in the posterior pole, an anatomical area of the eye which includes the optic nerve and macula (central retina), are of particular concern with regards to visual outcome, as radiation treatment to these areas for even the smallest of tumors is often associated with severe vision loss. The accurate diagnosis and treatment of small choroidal melanomas is critical to patient survival. When tumors with metastatic potential are recognized and treated at an early stage, survival prognosis improves dramatically.
The purpose of this study is to learn if malignant (life-threatening) choroidal tumors versus benign (non-life-threatening) tumors will show distinct blood vessel patterns using functional optical coherence tomography (OCT) angiography. Angiography is the mapping of blood vessels. The investigators believe that OCT angiography can provide data which may help in identifying life-threatening tumors at the earliest stages and improve overall survival for patients with this type of melanoma.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults older than age 18 with small (< 3mm) choroidal tumors located within the posterior pole region which can be imaged using OCT technology. Subjects with benign-appearing and malignant-appearing lesions meeting these criteria will be enrolled.
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.
- Patients receiving treatment for uveal melanomas will be excluded from the longitudinal natural history portion of this study, but may enroll for a single study visit prior to treatment of their melanoma. They will then be eligible to enroll in IRB 9501, which will follow radiation-treated patients longitudinally.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Choroidal Tumor Group
15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood vessel patterns in small choroidal tumors
Time Frame: 24 months
|
To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of potentially aggressive choroidal tumors.
This will be assessed using functional OCT angiography technology.
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alilson Skalet, MD, PhD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00009475
- IRB#00009475 (Other Identifier: OHSU Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small Posterior Choroidal Tumors
-
Hospices Civils de LyonCompletedPosterior Brain Fossa Tumors in ChildrenFrance
-
The Filatov Institute of Eye Diseases and Tissue...Odessa National Medical University; Mykolaiv Region Ophthalmogical Hospital; Central...Unknown
-
Changhua Christian HospitalCompletedChoroidal Neovascularization | Punctate Inner ChoroidopathyTaiwan
-
National Cancer Institute (NCI)CompletedIris Melanoma | Stage IV Uveal Melanoma | Medium/Large Size Posterior Uveal Melanoma | Recurrent Uveal Melanoma | Ocular Melanoma With Extraocular Extension | Small Size Posterior Uveal MelanomaUnited States, Canada
-
New England Retina AssociatesCompletedChoroidal MelanomaUnited States
-
New England Retina AssociatesGenentech, Inc.CompletedChoroidal MelanomaUnited States
-
New England Retina AssociatesCompleted
-
Institut CurieCompleted
-
Institut CurieCompletedChoroidal Melanoma, DiffuseFrance
-
Aura BiosciencesTerminatedChoroidal Melanoma | Indeterminate LesionsUnited States