Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine, a New Tracer PET, in the Diagnosis of Low Grade Glioma

Low Grade Glioma Clinical Trial

— PET-FETII  

Official title:

Evaluation de O-(2-[18F]-Fluoroethyl)-L-Tyrosine (or FET), a New Tracer PET (Positron Emission Tomography) , in the Diagnosis of Low Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286531
• Other study ID #: 08 111 01
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: August 18, 2015
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Determine the overall discriminatory ability of FET PET in the diagnosis of glioma grade II (referring to the current diagnostic gold standard represented by the histopathology exam of a tumor sample).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glioma
• Low Grade Glioma

Intervention

Drug:
• O-(2[18F]FLUOROETHYL)-L-TYROSINE
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)

Locations

Country	Name	City	State
France	CHU de CAEN	Caen
France	Hôpital de la Pitié Salpétrière	Paris
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		TEP and MRI Imagy 1 month before surgery	No
Secondary	- Determine the threshold with the highest positive likelihood ratio. - Determine the threshold with the highest positive likelihood ratio.		1 month before surgery	No
Secondary	Assess the concordance of the data-FET PET and MRI morphological data reported to histological diagnostic		1 month before surgery	No
Secondary	Evaluate the positive and negative predictive value of this threshold in order to improve the delineation of the tumor area		1 month before surgery	No