Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2013 |
| End Date: | November 2016 |
| Contact: | Michael Phillips, MD |
| Email: | mphillips@menssanaresearch.com |
| Phone: | 973-643-5464 |
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.
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.
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
We found this trial at
3
sites
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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