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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: June 2, 2014
Last verified: June 2014
History of Changes
  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: 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 ]
Enrollment: 2
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 2, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 25, 2015