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

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00904189
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irradiation; Adverse Effect	Radiation: Standard of care given for treatment of cancer	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• 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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Mean Dose of Radiation Received by Fingernails [2.5 years]

   The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).

Secondary Outcome Measures

1. Determination of the Range of Background Signal Measured by the EPR Device. [2.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Rochester
• ClinicalTrials.gov Identifier: NCT00904189
• Other Study ID Numbers: U4706; RSRB00014685
• First Posted: May 19, 2009
• Last Update Posted: Oct 19, 2015
• Last Verified: Sep 1, 2015

Study Results

Participant Flow

Arm/Group Title	1 Subjects Receiving Incidental Radiation Dose to Fingernails.
Arm/Group Description	Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation.
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	1Subjects Receiving Incidental Radiation Dose to Fingernails.
Arm/Group Description	Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%

Outcome Measures

1. Primary Outcome

Title	Mean Dose of Radiation Received by Fingernails
Description	The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).
Time Frame	2.5 years

Outcome Measure Data

Analysis Population Description

The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.

Arm/Group Title	Subjects Receiving Incidental Radiation Dose to Fingernails.
Arm/Group Description	Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation.
Measure Participants	0

2. Secondary Outcome

Title	Determination of the Range of Background Signal Measured by the EPR Device.
Time Frame	2.5 years

Outcome Measure Data

Analysis Population Description

The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.

Arm/Group Title	1 Subjects Receiving Incidental Radiation Dose to Fingernails.
Arm/Group Description	Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation.
Measure Participants	0

Adverse Events

Arm/Group Title	Subjects Receiving Incidental Radiation Dose to Fingernails.
Arm/Group Description	Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation.
All Cause Mortality
	Subjects Receiving Incidental Radiation Dose to Fingernails.
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Receiving Incidental Radiation Dose to Fingernails.
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Receiving Incidental Radiation Dose to Fingernails.
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.