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CancerFLTNCT00850278

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

A study testing FLT-PET imaging in people with Cancer and Brain Tumors, run by University Hospital, Caen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Brain Tumors
What is being tested?
FLT-PET imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
Oct 2008to Jul 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Caen University Hospital

    Caen, 14033

Other trials in France

About this study

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.

Conditions
Cancer, Brain Tumors
Being tested
FLT-PET imaging
Keywords
Brain tumor, [18F]FLT, [11C]MET, TEP-imaging, tumor cell proliferation
Medical subject headings
Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLT-PET imagingOther

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

Study groups in NCT00850278
Study groupRoleWhat they receive
FLT-PET imagingExperimentalPrior to surgical resection, patient will undergo [11C]MET PET imaging, [18F]FLT PET imaging, MRI, and spectroscopy imaging.
Receives: Other: FLT-PET imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 10

Secondary outcomes (3)

  1. To compare the efficiency of [18F]FLT with [11C]MET

    Measured: Day 15

  2. To define relations between [18F]FLT uptake and clinical, histological and radiological parameters

    Measured: Day 90

  3. To define relations between [18F]FLT uptake and patient survival

    Measured: J90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00850278
Sponsor's protocol ID
2007-006265-32
Acronym
FLT
Status last verified
Aug 2012
First submitted
23 Feb 2009
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26106569

Questions about this trial

What is this clinical trial studying?

A study testing FLT-PET imaging in people with Cancer and Brain Tumors, run by University Hospital, Caen at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT (time frame: Day 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00850278, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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