Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01424774
First received: August 25, 2011
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Determination of radiation exposure from Sr-82/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 "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 ] [ 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: 155
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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

  1. 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.
  2. 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.
  3. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Exclude a patient from this study if the patient has previously been 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: NCT01424774

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: NCT01424774     History of Changes
Other Study ID Numbers: CGEN-105
Study First Received: August 25, 2011
Last Updated: August 13, 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 August 27, 2014