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Blood Vessel Patterns in Small Choroidal Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01955915
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Alison Skalet, Oregon Health and Science University

Brief Summary:
The purpose of this study is to see if mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection.

Condition or disease
Small Posterior Choroidal Tumors

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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography
Actual Study Start Date : October 2013
Actual Primary Completion Date : April 2015
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Choroidal Tumor Group
15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will measure blood vessel pattern/flow changes in 15 patients with small posterior choroidal tumors.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01955915

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
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Principal Investigator: Alilson Skalet, MD, PhD OHSU Knight Cancer Institute

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Responsible Party: Alison Skalet, Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University Identifier: NCT01955915     History of Changes
Other Study ID Numbers: IRB00009475
IRB#00009475 ( Other Identifier: OHSU Institutional Review Board )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Alison Skalet, Oregon Health and Science University:
malignant melanoma
Additional relevant MeSH terms:
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Choroid Neoplasms
Uveal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Choroid Diseases
Uveal Diseases