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

Primary Purpose

Cancer, Brain Tumors

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FLT-PET imaging
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer focused on measuring Brain tumor, [18F]FLT, [11C]MET, TEP-imaging, tumor cell proliferation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Caen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLT-PET imaging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To compare the efficiency of [18F]FLT with [11C]MET
To define relations between [18F]FLT uptake and clinical, histological and radiological parameters
To define relations between [18F]FLT uptake and patient survival

Full Information

First Posted
February 23, 2009
Last Updated
August 31, 2012
Sponsor
University Hospital, Caen
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT00850278
Brief Title
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Acronym
FLT
Official Title
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Brain Tumors
Keywords
Brain tumor, [18F]FLT, [11C]MET, TEP-imaging, tumor cell proliferation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLT-PET imaging
Arm Type
Experimental
Arm Description
Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
Intervention Type
Other
Intervention Name(s)
FLT-PET imaging
Intervention Description
Prior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
Primary Outcome Measure Information:
Title
To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
To compare the efficiency of [18F]FLT with [11C]MET
Time Frame
Day 15
Title
To define relations between [18F]FLT uptake and clinical, histological and radiological parameters
Time Frame
Day 90
Title
To define relations between [18F]FLT uptake and patient survival
Time Frame
J90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Guillamo, MD, PhD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Michel Derlon, Pr
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

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

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