Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01424774|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : August 15, 2012
|Condition or disease||Intervention/treatment|
|Radiation Exposure||Drug: CardioGen-82|
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 Type :||Observational|
|Actual Enrollment :||155 participants|
|Official Title:||A Prospective Study to Estimate Inadvertent Radiation Exposure From Strontium Isotopes in Patients Who Have Undergone CardioGen-82® PET MPI Scanning|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
- Drug: CardioGen-82
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424774
|United States, New Jersey|
|Bracco Diagnostics, Inc.|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Steven Sireci, M.D.||Bracco Diagnostics, Inc|