- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02286531
Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine, a New Tracer PET, in the Diagnosis of Low Grade Glioma (PET-FETII)
Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low-grade glioma is a malignant tumor of young adults (12.5% of gliomas, incidence of 0.99 / 100,000). Median survival, linked to anaplastic transformation is estimated between 7 and 10 years, with great individual variability in the rate of evolution. The morphological MRI, standard assessment tool at present, suffers from many limitations, especially concerning the positive diagnosis, the targeting of surgical biopsies and tumor delineation which is essential to treatment The study design is a validation study of a new diagnostic procedure. This study is prospective, no randomized, multicenter involving 10 centers (Toulouse University Hospital, Caen, Tours, AP-HP Pitie Salpetriere, Lille, Angers, Rennes, Nîmes, Nantes and Nancy). Will be eligible patients in whom the diagnosis of grade II glioma is suspected according to clinical data and MRI, after evaluation and multidisciplinary meeting at which histological confirmation is scheduled within a maximum period of one month.
FET PET scans will be performed before any procedure or surgical treatment and the data will be merged with MRI. The gold standard is histological examination or biopsy material, or complete resection of the tumor. A minimum of three biopsies per patient will be realized. The pathologist will not see the results of PET-FET 100 patients will be enrolled over a period of 5 years. The area under the curve will be determined on a non-parametric for each increase in the value of PET-FET at near 10th. The sensitivities, specificities, positive predictive values will be estimated with confidence intervals at 95%. Factors to be considered in the analysis, the intrasubject variability related to the fact that several positive and negative results are found for each subject included. The concordance between the data-FET PET and MRI will be sought.
The expected benefits are a better diagnostic ability of PET-FET which results in a specific targeting of biopsies with fewer tests to false negatives and false positives, thus a better diagnostic yield of this invasive procedure. Furthermore, the characteristics of this test applied to all of the tumor may help to better define the limit between healthy and tumor areas and thus reduce the radiation fields to the volumes strictly necessary. These volumes are currently defined on the results of the only morphological MRI and can be further clarified
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Caen, France, 14033
- CHU de Caen
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Paris, France
- Hopital de la Pitie Salpetriere
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Toulouse, France, 31000
- UHToulouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients over 18 years
- Diagnosis of glioma grade II referred on clinical and MRI morphologic
- Realization of a brain MRI in preoperative condition of neuronavigation (MRI sequences including axial T2, Flair, T1, T1 with gadolinium) in a within 1 month with FET PET.
- Histological examination scheduled within one month with FET PET by resection (complete or partial) or by biopsy
- Patients who signed informed consent
- No against-indication for PET
- No against-indications to MRI
Exclusion Criteria:
- Grade II glioma who have received specific treatment with radiotherapy and or chemotherapy.
- Pregnant or breastfeeding women.
- Weight greater than 120 Kg
- against-indication to PET
- against- indication gadolinium
- Possible side effects to MRI (magnetic foreign bodies, pacemaker, congestive severe renal).)
- Patient under guardianship
- No coverage by social security
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FET imaging
FET Imaging.
Patient 0.1 mCi / kg (maximum 185 MBq) of FET with 'O-(2[18F]FLUOROETHYL)-L-TYROSINE' will be injected through the venous catheter.
At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes)
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Patient 0.1 mCi / kg (maximum 185 MBq) of FET will be injected through the venous catheter.
At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the overall discriminating capacity of FET-PET in the diagnosis of glioma grade II (referring to current diagnostic gold standard represented by the histopathological examination of a tumor sample).
Time Frame: TEP and MRI Imagy 1 month before surgery
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TEP and MRI Imagy 1 month before surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Determine the threshold with the highest positive likelihood ratio. - Determine the threshold with the highest positive likelihood ratio.
Time Frame: 1 month before surgery
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1 month before surgery
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Assess the concordance of the data-FET PET and MRI morphological data reported to histological diagnostic
Time Frame: 1 month before surgery
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1 month before surgery
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Evaluate the positive and negative predictive value of this threshold in order to improve the delineation of the tumor area
Time Frame: 1 month before surgery
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1 month before surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Payoux, MD PHD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08 111 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on O-(2[18F]FLUOROETHYL)-L-TYROSINE
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University of VirginiaRecruiting