Irradiation; Adverse EffectNCT00904189
Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR)
A study of Irradiation; Adverse Effect, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irradiation; Adverse Effect
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology, University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR) Spectroscopy
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.
Read the 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.
- Conditions
- Irradiation; Adverse Effect
- Being tested
- Standard of care given for treatment of cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care given for treatment of cancerRadiation
Subjects receiving a known dose of radiation during Total Body Irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care radiation therapy | No intervention | Standard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails. Receives: Radiation: Standard of care given for treatment of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2.5 years
Secondary outcomes (1)
Determination of the Range of Background Signal Measured by the EPR Device.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: PI has relocated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irradiation; Adverse EffectStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Swarts, PhD, Principal investigator, Department of Radiation Oncology, University of Rochester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904189
- Sponsor's protocol ID
- U4706
- Other IDs
- RSRB00014685
- Status last verified
- Sep 2015
- First submitted
- 15 May 2009
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Radiation Dose Cuticles Using Electron Paramagnetic Resonance (EPR) Spectroscopy
- ClinicalTrials.gov ID
- NCT00904189
- Acronym / sponsor ID
- U4706
- Conditions
- Irradiation; Adverse Effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has relocated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 May 2009 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care radiation therapy | No intervention | Radiation: Standard of care given for treatment of cancerStandard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care given for treatment of cancerSubjects receiving a known dose of radiation during Total Body Irradiation. | Radiation | Standard of care radiation therapy |
Primary outcome
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).
1 secondary outcome
Determination of the Range of Background Signal Measured by the EPR Device.
Time frame: 2.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Swarts, PhD principal investigator
Department of Radiation Oncology, University of Rochester Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Irradiation; Adverse Effect, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Dose of Radiation Received by Fingernails (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.