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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00850278
Other study ID # 2007-006265-32
Secondary ID
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


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
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