FLT-PET Imaging of Brain Tumors in Children

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Frederick Daniel Grant, Children's Hospital, Boston
ClinicalTrials.gov Identifier:
NCT01244737
First received: October 29, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA OOPD.


Condition Intervention Phase
Brain Neoplasms
Drug: [18F] FLT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • [18F] FLT uptake as a marker of cellular proliferation [ Time Frame: on average 1 week ] [ Designated as safety issue: No ]
    [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.


Secondary Outcome Measures:
  • Biodistribution of [18F]FLT [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    The distribution, localization, and kinetics of localization of [18F] FLT will be assessed by FLT-PET in 12 subjects.

  • Preliminary evaluation of clinical utility of [18F] FLT PET [ Time Frame: up to 2 years after enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: October 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: [18F] FLT
[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
  • 3'-deoxy-3'-[F-18] fluorothymidine
  • [18F] fluorothymidine
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.
Drug: [18F] FLT
[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
  • 3'-deoxy-3'-[F-18] fluorothymidine
  • [18F] fluorothymidine
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.
Drug: [18F] FLT
[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Other Names:
  • 3'-deoxy-3'-[F-18] fluorothymidine
  • [18F] fluorothymidine

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:

  1. Children with a new diagnosis of central nervous system tumor.
  2. Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
  3. 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01244737

Locations
United States, Massachusetts
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Frederick Daniel Grant
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Frederick D Grant, MD Children's Hospital, Boston, Harvard Medical School
  More Information

No publications provided

Responsible Party: Frederick Daniel Grant, Assistant Professor in Radiology, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT01244737     History of Changes
Other Study ID Numbers: IND 104365, R01FD003718
Study First Received: October 29, 2010
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
Brain neoplasms
Children
Positron-Emission Tomography
18F-FLT

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014