Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850278

Acronym

FLT

Enrollment

Registered

2009-02-24

Start date

2008-10-01

Completion date

2011-07-01

Last updated

2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors, Cancer

Keywords

Brain tumor, [18F]FLT, [11C]MET, TEP-imaging, tumor cell proliferation

Brief summary

The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.\[F-18\]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using \[11C\]MET tracer, immunohistochemical analysis and clinical parameters.

Interventions

OTHERFLT-PET imaging

Prior to surgical resection, patient will undergo \[11C\]MET PET imaging, \[18F\]FLT PET imaging, MRI, and spectroscopy imaging.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adults aged between 18 and 70 years * must have operable grade II, III or IV glioma, recurrent high grade glioma or brain metastases * KPS \>= 70% * must have the understanding and ability to sign an informed consent document * must have adequate liver and kidney function * be male or non-pregnant, non-lactating females * patients who are fertile must agree to use an effective method of contraception during participation in the study * the following laboratory results : absolute neutrophil count \>= 1500 cells/µl, platelet count \>= 100000 cells/µl, SGOT \<= 2.5 x ULN, serum creatinine \<= 1.5 x ULN.

Exclusion criteria

* contraindication to surgery * concomitant radio-, chemo-, or immunotherapy * history of significant dementia * known diagnosis of Human Immunodeficiency Virus (HIV) infection * patient with hepatitis B or C

Design outcomes

Primary

Measure	Time frame
To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT	Day 10

Secondary

Measure	Time frame
To compare the efficiency of [18F]FLT with [11C]MET	Day 15
To define relations between [18F]FLT uptake and clinical, histological and radiological parameters	Day 90
To define relations between [18F]FLT uptake and patient survival	J90

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Sébastien Guillamo, MD, PhD

University Hospital, Caen

STUDY_DIRECTORJean-Michel Derlon, Pr