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

Cancer Clinical Trial

— FLT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850278
• Other study ID #: 2007-006265-32
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: August 31, 2012
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT		Day 10	No
Secondary	To compare the efficiency of [18F]FLT with [11C]MET		Day 15	No
Secondary	To define relations between [18F]FLT uptake and clinical, histological and radiological parameters		Day 90	No
Secondary	To define relations between [18F]FLT uptake and patient survival		J90	No