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

NCT00904189 | Terminated Results

• 2 other identifiers: U4706RSRB00014685
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Irradiation; Adverse Effect

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determination of the Range of Background Signal Measured by the EPR Device.

  2.5 years

Study Arms (1)

Standard of care radiation therapy

NO INTERVENTION

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

Radiation: Standard of care given for treatment of cancer

Interventions

Standard of care given for treatment of cancer RADIATION

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

Standard of care radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Department of Radiation Oncology, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Results Point of Contact

• Title: Steven Swarts
• Organization: University of Rochester Medical Center

christine_huggins@urmc.rochester.edu

5852755623

Study Officials

• Steven Swarts, PhD

  Department of Radiation Oncology, University of Rochester Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 19, 2015
• Results First Posted: October 19, 2015

Record last verified: 2015-09

Locations

US (1)