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

NCT01424774 | Completed

• 1 other identifier: CGEN-105
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Exposure

Keywords

Radiation Exposure; Rubidium 82; Strontium 82; Strontium 85

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

CardioGen-82 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Exclude a patient from this study if the patient has previously been enrolled in and completed this study.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Location

Study Officials

• Steven Sireci, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

US (1)