Flare Measurements in Human Radiation Therapy Patients

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.

Study Overview

• Status: Completed
• Conditions: The Impact of Whole Body Irradiation on Ocular Flare

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients meeting the inclusion/exclusion criteria and receiving whole body irradiation at the UCLA Radiation Oncology clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular flare in radiotherapy patients	Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients.	Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment)

Collaborators and Investigators

• Sponsor: ChromoLogic, LLC
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Michell Kamrava, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Ocular flare
• Other Study ID Numbers: OCDOS_PRO_110314_02