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

This study has been terminated.
(PI has relocated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904189
First Posted: May 19, 2009
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Rochester
  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
Irradiation; Adverse Effect Radiation: Standard of care given for treatment of cancer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Mean Dose of Radiation Received by Fingernails [ Time Frame: 2.5 years ]
    The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).


Secondary Outcome Measures:
  • Determination of the Range of Background Signal Measured by the EPR Device. [ Time Frame: 2.5 years ]

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
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00904189     History of Changes
Other Study ID Numbers: U4706
RSRB00014685 ( Other Identifier: University of Rochester IRB )
First Submitted: May 15, 2009
First Posted: May 19, 2009
Results First Submitted: December 24, 2014
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015