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

This study has been terminated.
(PI has relocated)
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00904189
First received: May 15, 2009
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Whole-Body Irradiation
Radiation: Standard of care given for treatment of cancer

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR) Spectroscopy

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To determine dose-response relationships of EPR signal [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the range of background signal measured by the EPR device. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2007
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904189

Locations
United States, New York
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Steven Swarts, PhD Department of Radiation Oncology, University of Rochester Medical Center
  More Information

No publications provided

Responsible Party: Steven Swarts, PhD, Department of Radiation Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT00904189     History of Changes
Other Study ID Numbers: U4706, RSRB00014685
Study First Received: May 15, 2009
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014