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Clinical Trials/NCT00904189
NCT00904189
Terminated
Not Applicable

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

University of Rochester1 site in 1 country2 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irradiation; Adverse Effect
Sponsor
University of Rochester
Enrollment
2
Locations
1
Primary Endpoint
Mean Dose of Radiation Received by Fingernails
Status
Terminated
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
January 2008
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Determination of the Range of Background Signal Measured by the EPR Device.(2.5 years)

Study Sites (1)

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