A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00162045 |
Recruitment Status :
Completed
First Posted : September 13, 2005
Last Update Posted : June 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kawasaki Disease | Drug: Technetium Tc99m Sestamibi | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | June 2007 |

- Drug: Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
- 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 [ Time Frame: Following administration of Technetium Tc99m Sestamibi ]
- 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 [ Time Frame: Following administration of Technetium Tc99m Sestamibi ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162045
United States, Florida | |
Jackson Memorial Hospital | |
Miami, Florida, United States, 33136 | |
United States, Hawaii | |
Local Institution | |
Honolulu, Hawaii, United States, 96810 | |
United States, Illinois | |
University of Chicago Children's Hospital | |
Chicago, Illinois, United States, 60637 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 | |
United States, Wisconsin | |
Children's Hospital of Wisconsin | |
Wauwatosa, Wisconsin, United States, 29425 | |
Canada, British Columbia | |
Local Institution | |
Vancouver, British Columbia, Canada, V6H 3V4 | |
Taiwan | |
Local Institution | |
Changhua, Taiwan | |
Local Institution | |
Taichung, Taiwan |
Study Director: | Qi Zhu, MD | Lantheus Medical Imaging |
Responsible Party: | Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging |
ClinicalTrials.gov Identifier: | NCT00162045 |
Other Study ID Numbers: |
DuP 843-201 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | June 2, 2011 |
Last Verified: | June 2011 |
Mucocutaneous Lymph Node Syndrome Vasculitis Vascular Diseases Cardiovascular Diseases Lymphatic Diseases |
Skin Diseases, Vascular Skin Diseases Technetium Tc 99m Sestamibi Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |