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

Irradiation; Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00904189
• Other study ID #: U4706
• Secondary ID: RSRB00014685
• Status: Terminated
• Phase: N/A
• First received: May 15, 2009
• Last updated: September 18, 2015
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: September 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Irradiation; Adverse Effect

Intervention

Radiation:
• Standard of care given for treatment of cancer
Subjects receiving a known dose of radiation during Total Body Irradiation.

Locations

Country	Name	City	State
United States	Department of Radiation Oncology, University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Determination of the Range of Background Signal Measured by the EPR Device.		2.5 years	No