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

NCT00162045 | Completed Phase 1

• 1 other identifier: DuP 843-201
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 10

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.

Conditions

Kawasaki Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Technetium Tc99m Sestamibi DRUG

Rest and/or stress SPECT imaging study

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Have a terminal illness where expected survival is ≤6 months
• Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (10)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Local Institution

Honolulu, Hawaii, 96810, United States

Location

University of Chicago Children's Hospital

Chicago, Illinois, 60637, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

Children's Hospital of Wisconsin

Wauwatosa, Wisconsin, 29425, United States

Location

Local Institution

Vancouver, British Columbia, V6H 3V4, Canada

Location

Local Institution

Changhua, Taiwan

Location

Local Institution

Taichung, Taiwan

Location

Related Publications (1)

• Azarbar S, Salardini A, Dahdah N, Lazewatsky J, Sparks R, Portman M, Crane PD, Lee ML, Zhu Q. A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects. J Nucl Med. 2015 May;56(5):728-36. doi: 10.2967/jnumed.114.146795. Epub 2015 Apr 9.

  PMID: 25858045 DERIVED

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Study Officials

• Qi Zhu, MD

  Lantheus Medical Imaging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: January 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: June 2, 2011

Record last verified: 2011-06

Locations

US (7); TW (2); CA (1)