Blood Vessel Patterns in Small Choroidal Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01955915
First received: September 30, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Small Posterior Choroidal Tumors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Blood vessel patterns in small choroidal tumors [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Choroidal Tumor Group
15 patients diagnosed with small posterior choroidal tumors will be considered and evaluated for enrollment into this study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955915

Contacts
Contact: Denny Romfh 503-494-4351 romfhd@ohsu.edu
Contact: Janice Ladwig 503-494-8024 ladwig@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Denny Romfh    503-494-4351    romfhd@ohsu.edu   
Contact: Janice Ladwig    503-494-8024    ladwig@ohsu.edu   
Sub-Investigator: David Wilson, MD         
Sub-Investigator: David Huang, MD, PhD         
Sub-Investigator: Michael Chiang, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alilson Skalet, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: David Huang, Alison Skalet, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01955915     History of Changes
Other Study ID Numbers: IRB#00009475
Study First Received: September 30, 2013
Last Updated: April 7, 2014
Health Authority: Unites States: National Institutes of Health

Keywords provided by Oregon Health and Science University:
choroid
tumor
OCT
malignant melanoma

Additional relevant MeSH terms:
Choroid Neoplasms
Uveal Neoplasms
Eye Neoplasms
Neoplasms by Site
Neoplasms
Eye Diseases
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 28, 2014