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

Lantheus Medical Imaging

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kawasaki Disease

Treatments: Drug: Technetium Tc99m Sestamibi

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162045

DuP 843-201

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)