Flare Measurements in Human Radiation Therapy Patients

NCT ID: NCT01640236

Last Updated: 2014-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.

Detailed Description

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Conditions

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The Impact of Whole Body Irradiation on Ocular Flare

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
* Subjects must not have received ocular surgery for at least three months prior to study enrolment.
* Subjects must not have a history of uveitis.
* Subjects must have at least one eye free of cataracts
* Subject age must be greater than 18 years
* Subjects must have the ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

* Inability to give informed consent
* Cataracts in both eyes
* Subject has received ocular surgery within the prior three months
* Subject has a history of uveitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

ChromoLogic, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michell Kamrava, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Radiation Oncology

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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OCDOS_PRO_110314_02

Identifier Type: -

Identifier Source: org_study_id

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