NCT02152722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

May 23, 2014

Last Update Submit

April 6, 2015

Conditions

Radiation Injury

Keywords

Breath testVolatile Organic CompoundsVOCoxidative stressradiation biodosimetrymetabolomicsGCxGC TOF-MS

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing total body irradiation prior to chemotherapy.

You may qualify if:

  • 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

You may not qualify if:

  • \. Subject has had chemotherapy within preceding 21 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related 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.

    PMID: 23793046BACKGROUND

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Michael Phillips, M.D.

    Menssana Research, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Phillips, MD

CONTACT

973-643-5464mphillips@menssanaresearch.com

Peter Kaplan, PhD

CONTACT

973-643-5464pkaplan@menssanaresearch.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 2, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(3)