Non Invasive Detection of IDH1/2 Mutation in Gliomas

Glioma Clinical Trial

— IDASPE  

Official title:

Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597335
• Other study ID #: P120141
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2015
• Last updated: September 19, 2017
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: December 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marc Sanson, MD, PhD
• Phone: +331 42 16 03 91
• Email: marc.sanson[@]psl.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Affiliation to a social security system

2. Patient= 18 years old

3. Written informed consent

4. One of the two situations:

• presumed grade II-III glioma candidate to surgery (group 1)

• IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2)

5. Evaluable tumoral mass min diameter >2 cm (FLAIR)

6. PKPS > 60

Exclusion criteria

1. Contra-indication to MRI

2. Patient unable to give an written Informed Consent

3. Patient under guardianship or deprived of freedom

4. For group 2: patient already included in group 1

Related Conditions & MeSH terms

• Glioma
• IDH1/IDH2 Mutation

Intervention

Radiation:
• Spectro-MRI
Spectro-MRI for D-2HG detection

Other:
• Dosage of free circulating plasmatic DNA

• Dosage of D-2HG in the urine

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]	This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery	3 months after surgery
Secondary	SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]	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	evolution over 12 months