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

NCT02286531 | Completed

• 1 other identifier: 08 111 01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Low Grade Glioma

Keywords

: Low grade glioma; PET; FET; MRI; Standardized uptake value

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• - Determine the threshold with the highest positive likelihood ratio. - Determine the threshold with the highest positive likelihood ratio.

  1 month before surgery

• Assess the concordance of the data-FET PET and MRI morphological data reported to histological diagnostic

  1 month before surgery

• Evaluate the positive and negative predictive value of this threshold in order to improve the delineation of the tumor area

  1 month before surgery

Study Arms (1)

FET imaging

EXPERIMENTAL

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)

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

Interventions

O-(2[18F]FLUOROETHYL)-L-TYROSINE DRUG

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)

Also known as: FET imaging

FET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

CHU de CAEN

Caen, 14033, France

Location

Hôpital de la Pitié Salpétrière

Paris, France

Location

UHToulouse

Toulouse, 31000, France

Location

MeSH Terms

Interventions

O-(2-fluoroethyl)tyrosine

Study Officials

• Pierre Payoux, MD PHD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

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: November 4, 2014
• First Posted: November 10, 2014
• Study Start: June 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

FR (3)