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This study is to be performed at two clinical sites where patients received CardioGen-82 during the time period January to June, 2011 and where patients were scanned chronologically near to the index patients (2 days before or after). Of these, it is planned that at least 30 patients will be entered in this trial. Index patient is the term applied to individuals who had radiation spectra indicative of Sr-82 and Sr-85 detected by hand-held survey meters.
This clinical study protocol will use a three tier approach consisting of the following examinations:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioGen-82 | Drug | CardioGen-82 was not administered as part of this trial but the patients enrolled had to have received CardioGen-82 previously | ||
| CardioGen-82 | Drug | Patients do not received CardioGen-82 as part of this study. To be in the study they would have had to receive CardioGen-82 previously. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of radiation exposure from Sr-82 and/or Sr-85 | To determine radiation exposure from Sr-82 and/or Sr-85 in patients administered CardioGen-82® for PET MPI at the two sites reporting Sr-82/Sr-85 breakthrough | 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 | within 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
-Any patient previously enrolled in and completed this study.
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The study population would come from the two sites who administered CardioGen-82® to the index patients. Each site that agrees to participate will enroll patients administered CardioGen-82 2 days before and 2 days after the use of that generator.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Sireci, M.D. | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bracco Diagnostics, Inc. | Princeton | New Jersey | 08540 | United States |
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