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NCT Number: NCT01244737

FLT-PET Imaging of Brain Tumors in Children

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 Office of Orphan Product Development (OOPD)

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital, Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F] FLT

Drug

[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

Primary outcomes

  1. [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation

    Time frame: on average 1 week

    [18F] FLT uptake, as determined by pre-operative positron emission tomography (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.

  2. MIB Positive (Percent)

    Time frame: 30 days

    On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

Secondary outcomes

  1. Biodistribution of [18F]FLT

    Time frame: 6 hours

    The distribution, localization, and kinetics of localization of [18F] FLT will be assessed by FLT-PET in 12 subjects.

  2. Preliminary Evaluation of Clinical Utility of [18F] FLT PET

    Time frame: 3 months

    In individuals with a diagnosed primary brain tumor in whom therapy will include chemotherapy,.[18F] FLT uptake, as determined by positron emission tomography (PET) imaging, will assessed before and after two cycles of chemotherapy. Response will be determined by comparing the FL uptake before and after therapy.

Sponsors and collaborators

Lead sponsor

Frederick Daniel Grant

Other

Collaborators

  • Dana-Farber Cancer Institute

Registry information

Official study title

Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2010
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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