A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
This study has been completed.
Sponsor:
Lantheus Medical Imaging
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162045
First received: September 9, 2005
Last updated: June 1, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kawasaki Disease |
Drug: Technetium Tc99m Sestamibi |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Kawasaki disease
MedlinePlus related topics:
Kawasaki Disease
Drug Information available for:
Technetium Tc 99m sestamibi
U.S. FDA Resources
Further study details as provided by Lantheus Medical Imaging:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 79 |
| Study Start Date: | January 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162045
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162045
Locations
| 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 | |
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
| Study Director: | Qi Zhu, MD | Lantheus Medical Imaging |
More Information
No publications provided
| Responsible Party: | Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging |
| ClinicalTrials.gov Identifier: | NCT00162045 History of Changes |
| Other Study ID Numbers: | DuP 843-201 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Mucocutaneous Lymph Node Syndrome Cardiovascular Diseases Lymphatic Diseases Skin Diseases Skin Diseases, Vascular Vascular Diseases |
Vasculitis Technetium Tc 99m Sestamibi Diagnostic Uses of Chemicals Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiopharmaceuticals |
ClinicalTrials.gov processed this record on February 26, 2015