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

Completed

Conditions studied: Radiation Exposure

In brief

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.

Key facts

Study ID

NCT01424774

Run by

Bracco Diagnostics, Inc

People needed

155

Starts

2011-09-01

Expected to finish

2012-04-01

Last updated by the study team

2012-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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