Recruiting

Total Body Irradiation

Sponsor:

Menssana Research, Inc.

Code:

NCT02152722

Conditions

Radiation Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Radiation Injury

Study ID

NCT02152722

Start date

Sep, 2013

Status verified date

Apr, 2015

Completion date

Nov, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Total Body Irradiation Subjects

Subjects undergoing total body irradiation prior to chemotherapy. It is expected that all of these subjects will be receiving ablative radiation prior to bone marrow transplant. Breath will be collected before and after the first radiation exposure on each day of total body irradiation.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael Phillips, MD

973-643-5464mphillips@menssanaresearch.com

Peter Kaplan, PhD

973-643-5464pkaplan@menssanaresearch.com

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Mohammad Khan, M.D.

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator:

Scott Rowly, M.D.

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Chris Barker, M.D.

More Information

Sponsor

Menssana Research, Inc.

Last update posted

Apr 7, 2015

Last verified

Apr, 2015

Keywords

  • Breath test
  • Volatile Organic Compounds
  • VOC
  • oxidative stress
  • radiation biodosimetry
  • metabolomics
  • GCxGC TOF-MS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Menssana Research, Inc. on 2015-04-07.