- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244737
FLT-PET Imaging of Brain Tumors in Children
Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
Study Overview
Detailed Description
Although pediatric central nervous system tumors are rare, they are a significant contributor to morbidity and mortality in children. Tumor staging, detecting recurrent tumor, and assessing the response to therapy are critical in the treatment of brain tumors, but current imaging methods have major limitations in providing such information. The objective of this study is to validate 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) as a measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging agent in children with central nervous system tumors. The proposed studies will evaluate 18F-FLT PET in three groups:
- Children with a new diagnosis of central nervous system tumor.
- Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
- Children receiving post-operative chemotherapy for a central nervous system tumor.
In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for accurate identification of tumor recurrence, and for early assessment of the response to chemotherapy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital, Boston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 21 years or less
- capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
- Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
- Patients receiving steroids and/or anti-seizure medications are eligible
Exclusion Criteria:
- clinically active infection
- pregnancy or breast-feeding
- serious intercurrent medical illness
- require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: New diagnosis of brain tumor
In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using [18F] FLT.
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[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
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Experimental: Possible recurrent brain tumor
In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using [18F] PET.
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[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
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Experimental: Brain tumor response to chemotherapy
In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using [18F] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. |
[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[18F] FLT uptake as a marker of cellular proliferation
Time Frame: on average 1 week
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[18F] FLT uptake, as determined by pre-operative FLT-PET imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor.
This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.
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on average 1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodistribution of [18F]FLT
Time Frame: 6 hours
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The distribution, localization, and kinetics of localization of [18F] FLT will be assessed by FLT-PET in 12 subjects.
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6 hours
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Preliminary evaluation of clinical utility of [18F] FLT PET
Time Frame: up to 2 years after enrollment
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In subjects in Arm 3 (receiving chemotherapy), clinical data (date of recurrence and/or death) will be collected for up to 2 years to determine if [18F] FLT uptake after chemotherapy predicts clinical outcome.
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up to 2 years after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frederick D Grant, MD, Children's Hospital, Boston, Harvard Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IND 104365
- R01FD003718 (U.S. FDA Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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