Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

Radiation Injury Clinical Trial

Official title:

Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02152722
• Other study ID #: MR 2012 TBI
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2014
• Last updated: April 6, 2015
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: April 2015
• Source: Menssana Research, Inc.
• Contact: Michael Phillips, MD
• Phone: 973-643-5464
• Email: mphillips[@]menssanaresearch.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Radiation Injuries
• Radiation Injury

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Menssana Research, Inc.	Department of Health and Human Services, Emory University, Hackensack University Medical Center, Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Phillips M, Byrnes R, Cataneo RN, Chaturvedi A, Kaplan PD, Libardoni M, Mehta V, Mundada M, Patel U, Ramakrishna N, Schiff PB, Zhang X. Detection of volatile biomarkers of therapeutic radiation in breath. J Breath Res. 2013 Sep;7(3):036002. doi: 10.1088/1752-7155/7/3/036002. Epub 2013 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation volatile organic compound (VOC) score	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.	Each day of radiation exposure at time points between 1 day and 7 days post exposure.	No