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

NCT ID: NCT00904189

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-01-31

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.

Conditions

Irradiation; Adverse Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard of care radiation therapy

Standard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails.

Group Type: NO_INTERVENTION

Standard of care given for treatment of cancer

Intervention Type: RADIATION

Subjects receiving a known dose of radiation during Total Body Irradiation.

Interventions

Standard of care given for treatment of cancer

Subjects receiving a known dose of radiation during Total Body Irradiation.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Swarts, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, University of Rochester Medical Center

Locations

Department of Radiation Oncology, University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB00014685

Identifier Type: OTHER

Identifier Source: secondary_id

U4706

Identifier Type: -

Identifier Source: org_study_id