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

Not Applicable
Terminated
Conditions
Irradiation; Adverse Effect
Interventions
Radiation: Standard of care given for treatment of cancer
Registration Number
NCT00904189
Lead Sponsor
University of Rochester
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Standard of care radiation therapyStandard of care given for treatment of cancerStandard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails.
Primary Outcome Measures
NameTimeMethod
Mean Dose of Radiation Received by Fingernails2.5 years

The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).

Secondary Outcome Measures
NameTimeMethod
Determination of the Range of Background Signal Measured by the EPR Device.2.5 years

Trial Locations

Locations (1)

Department of Radiation Oncology, University of Rochester Medical Center

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Rochester, New York, United States

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