Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning at Two Clinical Sites

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01430975
First received: September 7, 2011
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Radiation Exposure
Drug: CardioGen-82

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Estimate Inadvertent Radiation Exposure From Strontium Isotopes in Patients Who Have Undergone CardioGen-82® PET MPI Scanning at Two Clinical Sites

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Determination of radiation exposure from Sr-82 and/or Sr-85 [ Time Frame: on average within 24 hours ] [ Designated as safety issue: Yes ]
    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

  • Determination of extent of SR-82/Sr-85 exposure, if positive exposure is detected [ Time Frame: within 2 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 72
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CardioGen-82
    CardioGen-82 was not administered as part of this trial but the patients enrolled had to have received CardioGen-82 previously
    Drug: CardioGen-82
    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.
Detailed Description:

This clinical study protocol will use a three tier approach consisting of the following examinations:

  • Patient examination with Survey Meter: The patient will first be tested at the clinical sites using a survey meter. 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.
  • 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 and 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Male or female;
  • Gave informed consent to participate in the study;
  • Received CardioGen-82 that has been eluted from the generator in close proximity (2 days before or after) the index patients.

Exclusion Criteria:

-Any patient previously enrolled in and completed this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430975

Locations
United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Steven Sireci, M.D. Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01430975     History of Changes
Other Study ID Numbers: CGEN-104
Study First Received: September 7, 2011
Last Updated: April 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bracco Diagnostics, Inc:
Radiation Exposure
Rubidium 82
Strontium 82
Strontium 85

ClinicalTrials.gov processed this record on September 16, 2014