Non Invasive Detection of IDH1/2 Mutation in Gliomas

Not Applicable

• Conditions: Glioma; IDH1/IDH2 Mutation
• Interventions: Radiation: Spectro-MRI; Other: Dosage of free circulating plasmatic DNA; Other: Dosage of D-2HG in the urine

• Registration Number: NCT02597335
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.

In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.

In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.

Detailed Description

The aim of this trial is to develop and validate a non invasive diagnostic approach of IDH1 mutated gliomas. It will evaluate the specificity and sensitivity of D-2HG detection by Brain Spectro MRI. This approach will be coupled with mutation detection from free plasmatic DNA and D-2HG dosage in urine samples.

The primary end-point is the quantification of D-2HG by spectro-MRI, and the correlation with the dosage of D-2HG in the tumor fragment, and the mutational status (group 1: 25 patients).

The secondary endpoints include:

1. longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)

2. Differentiation of tumor recurrence from radiation induced changes

3. Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Status Verified: 2016-12
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDH1/IDH2	Dosage of D-2HG in the urine	-
IDH1/IDH2	Spectro-MRI	-
IDH1/IDH2	Dosage of free circulating plasmatic DNA	-

Primary Outcome Measures

Name	Time	Method
D-2HG quantified by spectroMRI the measure of the ratio between two pics D-2HG and creatine [Time Frame: 3 months after surgery] [Designated as safety issue: No]	3 months after surgery	This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery

Secondary Outcome Measures

Name	Time	Method
SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]	evolution over 12 months	The ratio D-2HG/creatine will be evaluated overtime and correlated with radiological evolution and the response to treatment (group 2: 15 patients) every four months

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France