Radiation InjuryNCT02152722
Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
An observational study of Radiation Injury, run by Menssana Research, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Injury
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing total body irradiation prior to chemotherapy.
Who may be able to join
- Age 18 years or older
- Subject is willing and able to cooperate with study and give signed informed consent to participate
- Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
- 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
- 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
- Subject is an in-patient at the hospital
Who cannot join
- 1. Subject has had chemotherapy within preceding 21 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Mohammad Khan, M.D.
Mohammad Khan, M.D.
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Scott Rowly, M.D.
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Chris Barker, M.D.
About this study
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
- Keywords
- Breath test, Volatile Organic Compounds, VOC, oxidative stress, radiation biodosimetry, metabolomics, GCxGC TOF-MS
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each day of radiation exposure at time points between 1 day and 7 days post exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menssana Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Memorial Sloan Kettering Cancer Center, Emory University, Hackensack Meridian Health
- Responsible party
- Sponsor
- Investigators
- Michael Phillips, M.D., Principal investigator, Menssana Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152722
- Sponsor's protocol ID
- MR 2012 TBI
- Status last verified
- Apr 2015
- First submitted
- 23 May 2014
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23793046
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
- ClinicalTrials.gov ID
- NCT02152722
- Acronym / sponsor ID
- MR 2012 TBI
- Conditions
- Radiation Injury
- Keywords
- Breath test, Volatile Organic Compounds, VOC, oxidative stress, radiation biodosimetry, metabolomics, GCxGC TOF-MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Menssana Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Memorial Sloan Kettering Cancer Center, Emory University, Hackensack Meridian Health
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing total body irradiation prior to chemotherapy.
Key inclusion criteria (6 listed)
- Age 18 years or older
- Subject is willing and able to cooperate with study and give signed informed consent to participate
- Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
- 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
- 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
Key exclusion criteria (1 listed)
- 1. Subject has had chemotherapy within preceding 21 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Background: PubMed 23793046Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Phillips, M.D. principal investigator
Menssana Research, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injury, run by Menssana Research, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Phillips, MD (973-643-5464, mphillips@menssanaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.