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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technetium Tc99m Sestamibi | Drug | Rest and/or stress SPECT imaging study |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Zhu, MD | Lantheus Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25858045 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
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