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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Drug: CardioGen-82

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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bracco Diagnostics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	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

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 25, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 29, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Radiation Exposure; Rubidium 82; Strontium 82; Strontium 85
• Other Study ID Numbers: CGEN-105