Clinical trial NCT00162045: A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Official title: A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Kawasaki Disease
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 79
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: 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
timeFrame: Following administration of Technetium Tc99m Sestamibi
Secondary outcomes:
measure: 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
timeFrame: Following administration of Technetium Tc99m Sestamibi
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Honolulu
country: United States
facility: Local Institution
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Children's Hospital
state: Illinois
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
city: Wauwatosa
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Changhua
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Lantheus Medical Imaging
name: Qi Zhu, MD
role: STUDY_DIRECTOR
References:
citation: 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.