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

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

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.

Study Overview

• Status: Terminated
• Conditions: Irradiation; Adverse Effect
• Intervention / Treatment: Radiation: Standard of care given for treatment of cancer

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of the Range of Background Signal Measured by the EPR Device.	2.5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: September 18, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: U4706; RSRB00014685 (Other Identifier: University of Rochester IRB)