NCT00850278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 2, 2026

Status Verified

August 1, 2012

Enrollment Period

2.7 years

First QC Date

February 23, 2009

Last Update Submit

March 30, 2026

Conditions

CancerBrain Tumors

Keywords

Brain tumor[18F]FLT[11C]METTEP-imagingtumor cell proliferation

Outcome Measures

Primary Outcomes (1)

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

    Day 10

Secondary Outcomes (3)

  • 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

Study Arms (1)

FLT-PET imaging

EXPERIMENTAL

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

Other: FLT-PET imaging

Interventions

FLT-PET imagingOTHER

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

FLT-PET imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

Related Publications (1)

  • Collet S, Valable S, Constans JM, Lechapt-Zalcman E, Roussel S, Delcroix N, Abbas A, Ibazizene M, Bernaudin M, Barre L, Derlon JM, Guillamo JS. [(18)F]-fluoro-L-thymidine PET and advanced MRI for preoperative grading of gliomas. Neuroimage Clin. 2015 May 29;8:448-54. doi: 10.1016/j.nicl.2015.05.012. eCollection 2015.

    PMID: 26106569RESULT

MeSH Terms

Conditions

NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jean-Sébastien Guillamo, MD, PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Jean-Michel Derlon, Pr

    University Hospital, Caen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 2, 2026

Record last verified: 2012-08

Locations

FR(1)