Clinical Trial: Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

Brief Summary:

The effect of radiation on normal tissue varies widely between individuals. Consequently, a test to measure tissue response to radiation could be clinically useful by permitting more accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging concerns about possible nuclear terrorism a test for exposure to radiation might also be useful in evaluating victims of a "dirty bomb" explosion. A number of different techniques have been previously reported in epidemiological studies for the estimation of prior radiation exposure. This study explores one approach to estimating radiation exposure by measurement of increased oxidative stress which can be detected by a breath test.

In this study subjects undergoing significant exposure to therapeutic radiation will provide breath samples for analysis in a central laboratory. The hypothesis of the study is that the analysis of these samples will lead to the identification of a set of markers of radiation exposure.


Detailed Summary:
Sponsor: Menssana Research, Inc.

Current Primary Outcome: Radiation volatile organic compound (VOC) score [ Time Frame: Each day of radiation exposure at time points between 1 day and 7 days post exposure. ]

An algorithm for scoring the radiation exposure based on analysis of breath samples will be developed and applied to each breath sample collected. The hypothesis is that the scores will indicate radiation exposure, specifically exposure to more than 2 Gray at time points between 1 day and 7 days post exposure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Menssana Research, Inc.

Dates:
Date Received: May 23, 2014
Date Started: September 2013
Date Completion: November 2016
Last Updated: April 6, 2015
Last Verified: April 2015