Radiation ExposureNCT01424774
Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning
An observational study of Radiation Exposure, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
This study will be performed at clinical sites that have administered CardioGen-82® to patients from January to July 2011. The patients enrolled(i.e., "target date patients") will be all those who were dosed at the end of use of the CardioGen-82® generators on the last day of generator use from the generator that was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- CardioGen-82
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population would come from sites who administered CardioGen-82® during the time period of January 2011 to July 2011. The patient population is expected to be patients (i.e., target date patients) who were administered Caridogen-82 that had been eluted from the generator on the last usage day the generator was used prior to the generator that was recalled (i.e., target date generator). It is planned to enroll 100 patients in this study. Each site that agrees to participate will be encouraged to enroll at least 1 patient. Depending on the number of sites agreeing to participate, the enrollment time frame may be extended to include the last 3 to 5 days of generator usage.
Who may be able to join
- Enroll a patient in this study if the patient meets the following inclusion criteria:
- Male or female
- Gave informed consent to participate in the study
- Received CardioGen-82® that had been eluted from the generator on the last usage day the generator was used prior to the generator that was recalled.
Who cannot join
- Exclude a patient from this study if the patient has previously been enrolled in and completed this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540
About this study
Official title: A Prospective Study to Estimate Inadvertent Radiation Exposure From Strontium Isotopes in Patients Who Have Undergone CardioGen-82® PET MPI Scanning
This study will be performed at clinical sites that have administered CardioGen-82® to patients from January to July 2011. The patients enrolled(i.e., "target date patients") will be all those who were dosed at the end of use of the CardioGen-82® generators on the last day of generator use from the generator that was used immediately prior to the recalled generator (i.e., "target date generators"). These are not patients who received drug eluted from the recalled generator. Of these patients, it is planned that 100 patients will be entered in this trial.
Read the detailed description
This clinical study protocol will use a three tier approach consisting of the following examinations:
- Patient examination with Survey Meter: Patients who agree to be tested at the clinical sites will be first evaluated using a survey meter. In those patients in whom radiation count is ≥ 2 times above background count using a standard survey meter, the presence of Sr-82 and/or Sr-85 will be assessed through a quantitative reading from a calibrated portable isotope identifier.
- Patient examination with Portable Isotope Identifier: This examination will be done by use of a portable isotope identifier, which will be supplied by the Sponsor to the study sites. An assessor, independent to the study site, will perform the examination. In those patients whose radiation count is ≥ 2 times above background count using a standard survey meter, the presence of Sr-82 and/or Sr-85 will be assessed through a quantitative reading from a calibrated portable isotope identifier. The reading will be forwarded along with the date of the reading, the date of the patient's CardioGen-82® scan, and the total dose of CardioGen-82® administered to the patient, to an independent medical expert, independent to the study site, who will back-calculate an estimated dose of Sr-82 and/or Sr-85 from these data.
- Patient examination at Oak Ridge National Laboratory: Any patient whose estimated dose of Sr-82 exceeds the specified limit of 0.02 microcuries per mCi Rb-82 administered, and/or whose estimated dose of Sr-85 exceeds the specified limit of 0.2 microcuries per mCi Rb-82 administered, will be asked to travel to Oak Ridge National Laboratory in Tennessee, for accurate whole body scanning. Scan data from Oak Ridge National Laboratories will be analyzed by one or more independent medical experts to accurately back-calculate exposure to Sr-82 and/or Sr-85, and to estimate health hazard for the patient.
- Conditions
- Radiation Exposure
- Being tested
- CardioGen-82
- Keywords
- Radiation Exposure, Rubidium 82, Strontium 82, Strontium 85
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioGen-82Drug
CardioGen-82 is not administered to patients in this study, however to be able to qualify for enrollment, the patients must have received CardioGen previously
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of radiation exposure from Sr-82/Sr-85
To determine radiation exposure from Sr-82 and/or Sr-85 in "target date patients" administered CardioGen-82® for PET MPI. "Target date patients" are defined as patients who were administered CardioGen-82® eluted on the last day of generator use from the generator that was used immediately prior to the recalled generator (i.e., "target date generator").
Measured: on average within 24 hours
Determination of extent of Sr-82/Sr-85 exposure, if positive exposure is detected
To determine the extent of the Sr-82/Sr-85 exposure, in the subset of patients with positive testing exceeding the specified threshold for the breakthrough of Sr-82/Sr-85, by performing whole body scanning at Oak Ridge National Laboratory for eventual health hazard assessment.
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Sireci, M.D., Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424774
- Sponsor's protocol ID
- CGEN-105
- Status last verified
- Aug 2012
- First submitted
- 25 Aug 2011
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Estimate Inadvertent Radiation Exposure From Strontium Isotopes in Patients Who Have Undergone CardioGen-82® PET MPI Scanning
- ClinicalTrials.gov ID
- NCT01424774
- Acronym / sponsor ID
- CGEN-105
- Conditions
- Radiation Exposure
- Keywords
- Radiation Exposure, Rubidium 82, Strontium 82, Strontium 85
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be performed at clinical sites that have administered CardioGen-82® to patients from January to July 2011. The patients enrolled(i.e., "target date patients") will be all those who were dosed at the end of use of the CardioGen-82® generators on the last day of generator use from the generator that was used immediately prior to the recalled generator (i.e., "target date generators"). These are not patients who received drug eluted from the recalled generator. Of these patients, it is planned that 100 patients will be entered in this trial.
Detailed description
This clinical study protocol will use a three tier approach consisting of the following examinations:
- Patient examination with Survey Meter: Patients who agree to be tested at the clinical sites will be first evaluated using a survey meter. In those patients in whom radiation count is ≥ 2 times above background count using a standard survey meter, the presence of Sr-82 and/or Sr-85 will be assessed through a quantitative reading from a calibrated portable isotope identifier.
- Patient examination with Portable Isotope Identifier: This examination will be done by use of a portable isotope identifier, which will be supplied by the Sponsor to the study sites. An assessor, independent to the study site, will perform the examination. In those patients whose radiation count is ≥ 2 times above background count using a standard survey meter, the presence of Sr-82 and/or Sr-85 will be assessed through a quantitative reading from a calibrated portable isotope identifier. The reading will be forwarded along with the date of the reading, the date of the patient's CardioGen-82® scan, and the total dose of CardioGen-82® administered to the patient, to an independent medical expert, independent to the study site, who will back-calculate an estimated dose of Sr-82 and/or Sr-85 from these data.
- Patient examination at Oak Ridge National Laboratory: Any patient whose estimated dose of Sr-82 exceeds the specified limit of 0.02 microcuries per mCi Rb-82 administered, and/or whose estimated dose of Sr-85 exceeds the specified limit of 0.2 microcuries per mCi Rb-82 administered, will be asked to travel to Oak Ridge National Laboratory in Tennessee, for accurate whole body scanning. Scan data from Oak Ridge National Laboratories will be analyzed by one or more independent medical experts to accurately back-calculate exposure to Sr-82 and/or Sr-85, and to estimate health hazard for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population would come from sites who administered CardioGen-82® during the time period of January 2011 to July 2011. The patient population is expected to be patients (i.e., target date patients) who were administered Caridogen-82 that had been eluted from the generator on the last usage day the generator was used prior to the generator that was recalled (i.e., target date generator). It is planned to enroll 100 patients in this study. Each site that agrees to participate will be encouraged to enroll at least 1 patient. Depending on the number of sites agreeing to participate, the enrollment time frame may be extended to include the last 3 to 5 days of generator usage.
Key inclusion criteria (4 listed)
- Male or female
- Gave informed consent to participate in the study
- Received CardioGen-82® that had been eluted from the generator on the last usage day the generator was used prior to the generator that was recalled.
Key exclusion criteria (1 listed)
- Exclude a patient from this study if the patient has previously been enrolled in and completed this study.
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 |
|---|---|---|
| CardioGen-82CardioGen-82 is not administered to patients in this study, however to be able to qualify for enrollment, the patients must have received CardioGen previously | Drug | – |
Primary outcome
Determination of radiation exposure from Sr-82/Sr-85
Time frame: on average within 24 hours
To determine radiation exposure from Sr-82 and/or Sr-85 in "target date patients" administered CardioGen-82® for PET MPI. "Target date patients" are defined as patients who were administered CardioGen-82® eluted on the last day of generator use from the generator that was used immediately prior to the recalled generator (i.e., "target date generator").
Determination of extent of Sr-82/Sr-85 exposure, if positive exposure is detected
Time frame: within 2 weeks
To determine the extent of the Sr-82/Sr-85 exposure, in the subset of patients with positive testing exceeding the specified threshold for the breakthrough of Sr-82/Sr-85, by performing whole body scanning at Oak Ridge National Laboratory for eventual health hazard assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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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 Sireci, M.D. study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by Bracco Diagnostics, Inc 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 1 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: finished, as of the sponsor's last update on 15 Aug 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of radiation exposure from Sr-82/Sr-85 (time frame: on average within 24 hours). The study lists 2 primary outcomes in all. 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 15 Aug 2012.