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High-grade GliomaPhase 1/2GLIO-TEPNCT00624728

Assessment of 18FLT PET-CT for Volume Definition of High-grade Gliomas (GLIO-TEP)

A Phase 1/2 study testing 18F Fluorothymidine PET CT in people with High-grade Glioma and Astrocytoma, run by University Hospital, Bordeaux at 2 sites 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

18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High-grade Glioma, Astrocytoma, Glioblastoma
What is being tested?
18F Fluorothymidine PET CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesFrance
Study dates
Feb 2008to Nov 2011
Phase
Phase 1/2
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

  • patients over 18
  • suspicion of malignant glioma on MRI aspect
  • surgical indication with neuronavigation
  • signed informed consent
  • absence of contraindication for MRI
  • absence of pregnancy or breast-feeding

Who cannot join

  • women : pregnancy or breast-feeding or no oral or intra-uterine contraception (if not post-menopause)
  • secondary exclusion if high grade glioma diagnostic (glioblastoma or astrocytoma grade III) is not confirmed after surgery with histopathology

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital St André, CHU de Bordeaux

    Bordeaux, 33000

  • Hôpital Pellegrin-tripode , CHU de Bordeaux

    Bordeaux, 33076

Other trials in France

About this study

Official title: Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. In our project, we want to compare the tumoral volumes obtained with PET and MRI, with the gold standard histopathological diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET volume to better delineate tumoral volume in radiotherapeutic management of gliomas.

Read the detailed description
  • Background: 18FDG is the most widely used tracer for oncologic positron emission tomography (PET). However, the high glucose utilization of normal gray matter limits its utility in brain explorations. More recently, 18FLT was introduced as a PET tracer for tumor imaging. It has been found useful for non-invasive assessment of the proliferation status of various tumors. Its potential clinical use in the evaluation of brain tumors has not been clearly determined because of sparse studies.
  • The primary objective of this study is to assess the positive predictive value of PET-CT uptake of 18FLT in diagnosing malignant tissue by comparison with the histopathological gold standard diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, at the time of preoperative evaluation.
  • Secondary objectives are: to describe and compare preoperative tumor volumes and postoperative residual tumor volumes as assessed by 18FLT PET-CT and MRI, and to describe a quantitative proliferation index with PET (SUV for "standardized uptake value").
  • Study design: This is an exploratory cross-sectional study at two separate times: pre-and postoperative. Eligible patients will be included consecutively. Histological samples will be analyzed blindly to imaging data. Assessments of PET-CT and MRI volumes will be blind to each other.
  • Procedure: After information and written informed consent and before surgery, patients will undergo MRI and 18F-FLT PET-CT to obtain the tumor volume according to both modalities. Then, surgeons will make different biopsies from i) areas with MR abnormalities and FLT uptake, ii) area with FLT uptake and no MR abnormality (on the surgery approach way or in not functional areas), iii) area with MR abnormality without any FLT uptake, iiii) area without any uptake where biopsy is possible because the area is on the surgery approach way. Then, the samples will be blindly analyzed to determine the Ki-67 proliferation index and WHO grading malignancy scale. Patients will undergo again 18F-FLT PET-TDM and MRI at least 4 weeks after surgery, in the week preceding radiotherapy, to determine residual tumor volumes.
Being tested
18F Fluorothymidine PET CT
Keywords
Positron-Emission Tomography, Alovudine [Substance Name], 18F-FLT, Magnetic Resonance Imaging, Astrocytoma, Glioblastoma
Medical subject headings
Glioma, Astrocytoma, Glioblastoma

What participants receive

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

  • 18F Fluorothymidine PET CTRadiation

    18 FLT will be provided by the Laboratoire des Radiopharmaceutiques- Université Bordeaux2, Hôpital Xavier Arnozan and prepared according to the method described by Grierson and Shields ( Grierson J, Shields A. Nucl Med Biol 27 :143-156 ; 2000).

    Specific activity of 18FLT will be more than 37 GBq/µmol (>1Ci/µmol) corrected for decay at the end of bombardment of cyclotron target. Before tracer injection to patients, each dosis will be tested for pH and for radiochemical purity (> 95%) via HPLC technique and thin layer chromatography.

    18FLT dosis will be injected intravenously to the patients (10 mL of salted isotonic solution with less than 10 % (v/v) of ethanol (USP). Administrated activity will be calculated estimating total body surface of patient (2,6 MBq/kg ou 0,07 mCi/kg) with maximal activity of 185 MBq.

    PET acquisition will be realized as follows : Dynamic acquisition in 3D mode for 35 min, Iterative reconstruction (OSEM) with and without attenuation correction.

Study groups in NCT00624728
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Radiation: 18F Fluorothymidine PET CT

What is being measured

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

  1. Predictive positive value of PET uptake for detection of malignant tissue (defined with Ki-67 proliferation index >15% in PET+ volumes)

    Measured: before and during surgery

Secondary outcomes (2)

  1. Comparison of volumes defined by PET and MRI

    Measured: before surgery and 4 weeks after surgery

  2. Description of a quantitative PET proliferation index ("standardized uptake value")

    Measured: before surgery and 4 weeks after surgery

Timeline

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

  1. First posted27 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionNov 2011
  4. Study completionNov 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 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00624728
Sponsor's protocol ID
9420-04
Other IDs
2004-033
Acronym
GLIO-TEP
Status last verified
May 2012
First submitted
15 Feb 2008
Last updated
4 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, Ra YS, Yeo JS, Ryu JS, Moon DH. [18F]3'-deoxy-3'-fluorothymidine PET for the diagnosis and grading of brain tumors. Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. doi: 10.1007/s00259-004-1742-3. Epub 2005 Feb 15.

    PubMed 15711980

  • Chen W, Cloughesy T, Kamdar N, Satyamurthy N, Bergsneider M, Liau L, Mischel P, Czernin J, Phelps ME, Silverman DH. Imaging proliferation in brain tumors with 18F-FLT PET: comparison with 18F-FDG. J Nucl Med. 2005 Jun;46(6):945-52.

    PubMed 15937304

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 18F Fluorothymidine PET CT in people with High-grade Glioma and Astrocytoma, run by University Hospital, Bordeaux at 2 sites 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 6 inclusion and 2 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 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Predictive positive value of PET uptake for detection of malignant tissue (defined with Ki-67 proliferation index >15% in PET+ volumes) (time frame: before and during surgery). 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 NCT00624728, which also lists 2 linked publications.

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 4 May 2012.

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