Clinical trial NCT00904189: Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR)
Official title: Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR) Spectroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irradiation; Adverse Effect
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Mean Dose of Radiation Received by Fingernails
timeFrame: 2.5 years
Secondary outcomes:
measure: Determination of the Range of Background Signal Measured by the EPR Device.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Radiation Oncology, University of Rochester Medical Center
state: New York
Study officials:
affiliation: Department of Radiation Oncology, University of Rochester Medical Center
name: Steven Swarts, PhD
role: PRINCIPAL_INVESTIGATOR
References: