Kawasaki DiseasePhase 1/2NCT00162045
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
A Phase 1/2 study testing Technetium Tc99m Sestamibi in people with Kawasaki Disease, run by Lantheus Medical Imaging at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Technetium Tc99m Sestamibi
- How many people
- 79 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2005to Jun 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Have a terminal illness where expected survival is ≤6 months
- Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Children's Hospital
Chicago, Illinois, 60637
Local Institution
Honolulu, Hawaii, 96810
Jackson Memorial Hospital
Miami, Florida, 33136
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
Children's Hospital of Wisconsin
Wauwatosa, Wisconsin, 29425
About this study
Official title: A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects
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
- Being tested
- Technetium Tc99m Sestamibi
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium Tc99m SestamibiDrug
Rest and/or stress SPECT imaging study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Following administration of Technetium Tc99m Sestamibi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionMay 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Qi Zhu, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162045
- Sponsor's protocol ID
- DuP 843-201
- Status last verified
- Jun 2011
- First submitted
- 9 Sep 2005
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25858045
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00162045
- Acronym / sponsor ID
- DuP 843-201
- Conditions
- Kawasaki Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Have a terminal illness where expected survival is ≤6 months
- Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technetium Tc99m SestamibiRest and/or stress SPECT imaging study | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Derived from this study: PubMed 25858045Azarbar 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Zhu, MD study director
Lantheus Medical Imaging
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Technetium Tc99m Sestamibi in people with Kawasaki Disease, run by Lantheus Medical Imaging at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Taiwan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Following administration of Technetium Tc99m Sestamibi). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.