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Spots Global Cancer Trial Database for FLT-PET Imaging of Brain Tumors in Children

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Trial Identification

Brief Title: FLT-PET Imaging of Brain Tumors in Children

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

Study ID: NCT01244737

Conditions

Brain Neoplasms

Interventions

[18F] FLT

Study Description

Brief Summary: 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)

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

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital, Boston, Boston, Massachusetts, United States

Contact Details

Name: Frederick D Grant, MD

Affiliation: Children's Hospital, Boston, Harvard Medical School

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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