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

A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

Sponsors

Lead Sponsor: Lantheus Medical Imaging

Source Lantheus Medical Imaging
Brief 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.

Overall Status Completed
Start Date January 2005
Completion Date June 2007
Primary Completion Date May 2007
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours Following administration of Technetium Tc99m Sestamibi
Secondary Outcome
Measure Time Frame
A determination of the safety of Sestamibi will be evaluated at the end of the study through adverse and serious adverse events reported and evaluating vital signs, ECGs, physical exams and laboratory tests for each subject Following administration of Technetium Tc99m Sestamibi
Enrollment 79
Condition
Intervention

Intervention Type: Drug

Intervention Name: Technetium Tc99m Sestamibi

Description: Rest and/or stress SPECT imaging study

Eligibility

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).

Gender: All

Minimum Age: 4 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Qi Zhu, MD Study Director Lantheus Medical Imaging
Location
Facility:
Jackson Memorial Hospital | Miami, Florida, 33136, United States
Local Institution | Honolulu, Hawaii, 96810, United States
University of Chicago Children's Hospital | Chicago, Illinois, 60637, United States
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina | Charleston, South Carolina, 29425, United States
Children's Hospital and Regional Medical Center | Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin | Wauwatosa, Wisconsin, 29425, United States
Local Institution | Vancouver, British Columbia, V6H 3V4, Canada
Local Institution | Changhua, Taiwan
Local Institution | Taichung, Taiwan
Location Countries

Canada

Taiwan

United States

Verification Date

June 2011

Responsible Party

Name Title: Qi Zhu, MD Senior Medical Director

Organization: Lantheus Medical Imaging

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov