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

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University of Rochester

Status

Terminated

Conditions

Irradiation; Adverse Effect

Treatments

Radiation: Standard of care given for treatment of cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT00904189
RSRB00014685 (Other Identifier)
U4706

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Standard of care radiation therapy
No Intervention group
Description:
Standard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails.
Treatment:
Radiation: Standard of care given for treatment of cancer

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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