Irradiation; Adverse Effect
Conditions
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.
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.
Interventions
RADIATIONStandard of care given for treatment of cancer
Subjects receiving a known dose of radiation during Total Body Irradiation.
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Determination of the Range of Background Signal Measured by the EPR Device. | 2.5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1Subjects Receiving Incidental Radiation Dose to Fingernails. 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | 1Subjects Receiving Incidental Radiation Dose to Fingernails. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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).
Time frame: 2.5 years
Population: 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.
Secondary
Determination of the Range of Background Signal Measured by the EPR Device.
Time frame: 2.5 years
Population: 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.