Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR)

Study Description

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Brief Summary:

This study is to test the effectiveness a new method (called EPR dosimetry) that could be used to measure radiation doses to fingernails that occur as a result of unplanned exposure to radiation, such as might occur from the actions of terrorists, or from accidents.

Condition or disease	Intervention/treatment	Phase
Irradiation; Adverse Effect	Radiation: Standard of care given for treatment of cancer	Not Applicable

Detailed Description:

In the event of a radiological exposure incident, such as the detonation of a radiological dispersion device (RDD) in a terrorist attack or accidental exposures to sources of ionizing radiation, it is advantageous to use multiple methods to assess the dosimetry of individuals exposed to this radiation (4). These methods should include a physical assessment of the dosimetry at the exposure site to, 1) identify the type of radiation (e.g., gamma rays, neutrons or radioisotopes), 2) evaluate the distribution of radioisotopes and/or radioactivity at the site, and 3) determine the location of exposed individuals to the source of radiation. For individuals affected by the radiological incident, the monitoring of their clinical signs and symptoms is important for determining whether acute symptoms of radiation sickness are being presented and if immediate medical intervention is required. However, it is recognized that an invaluable aid for the clinical management of exposed individuals is the use of biomarkers that can be readily obtained from the exposed individual and used for assessing dosimetry (4,9). Biomarkers that are most useful to the physician are those produced or expressed within minutes to hours following exposure. With the dosimetry provided through these early phase biomarker measurements, the physician can better assess the clinical signs that are presented by an exposed individual and better determine the need and course of treatment.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR) Spectroscopy
Study Start Date :	November 2007
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	January 2008

Arms and Interventions

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Arm	Intervention/treatment
No Intervention: Standard of care radiation therapy; Standard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails.	Radiation: Standard of care given for treatment of cancer; Subjects receiving a known dose of radiation during Total Body Irradiation.

Outcome Measures

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Primary Outcome Measures :

1. Mean Dose of Radiation Received by Fingernails [ Time Frame: 2.5 years ]
   The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).

Secondary Outcome Measures :

1. Determination of the Range of Background Signal Measured by the EPR Device. [ Time Frame: 2.5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Arm 1:

• Radiation field to include one or more fingernail or toenail;
• KPS > 70;
• For TBI subjects: sufficient cuticle length (3 mm or greater) on all fingers and/or toes.

Exclusion Criteria:

• Prior therapeutic radiation doses to the fingernails;
• Life expectancy < 6 months;
• lifetime radiation dose of greater than 0.1 Gy through prior radiation therapy or occupational exposures.

Contacts and Locations

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Locations

United States, New York
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:	Steven Swarts, PhD	Department of Radiation Oncology, University of Rochester Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00904189 History of Changes
Other Study ID Numbers:	U4706; RSRB00014685 ( Other Identifier: University of Rochester IRB )
First Posted:	May 19, 2009
Results First Posted:	October 19, 2015
Last Update Posted:	October 19, 2015
Last Verified:	September 2015