Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

• Conditions: Radiation Injury

• Registration Number: NCT02152722
• Lead Sponsor: Menssana Research, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07
• Primary Completion: 2016-07
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age 18 years or older
2. Subject is willing and able to cooperate with study and give signed informed consent to participate
3. Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
4. Actively smoking subjects, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded
5. Subject will be available for follow-up breath tests following each session of TBI. Subjects receiving only one day of TBI will be available for a follow-up 24-36 hours following TBI
6. Subject is an in-patient at the hospital

Exclusion Criteria

1. Subject has had chemotherapy within preceding 21 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation volatile organic compound (VOC) score	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.

Trial Locations

Locations (3)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States