NCT01640236

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

July 10, 2012

Last Update Submit

July 14, 2014

Conditions

The Impact of Whole Body Irradiation on Ocular Flare

Keywords

Ocular flare

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Radiation Oncology

Los Angeles, California, 90095, United States

Location

Study Officials

  • Michell Kamrava, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 13, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

US(1)