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

NCT01430975 | Completed

• 1 other identifier: CGEN-104
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Exposure

Keywords

Radiation Exposure; Rubidium 82; Strontium 82; Strontium 85

Outcome Measures

Primary Outcomes (2)

• Determination of radiation exposure from Sr-82 and/or Sr-85

  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

  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 was not administered as part of this trial but the patients enrolled had to have received CardioGen-82 previously

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Any patient previously 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: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

US (1)