A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lantheus Medical Imaging
• Treatments: Technetium Tc 99m Sestamibi

Criteria

Inclusion Criteria:

• Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan.

• Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation.

Exclusion Criteria:

• Have a terminal illness where expected survival is ≤6 months

• Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).