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Non Invasive Detection of IDH1/2 Mutation in Gliomas

NCT ID: NCT02597335

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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

Conditions

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Glioma IDH1/IDH2 Mutation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IDH1/IDH2

Group Type EXPERIMENTAL

Spectro-MRI

Intervention Type RADIATION

Spectro-MRI for D-2HG detection

Dosage of free circulating plasmatic DNA

Intervention Type OTHER

Dosage of D-2HG in the urine

Intervention Type OTHER

Interventions

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Spectro-MRI

Spectro-MRI for D-2HG detection

Intervention Type RADIATION

Dosage of free circulating plasmatic DNA

Intervention Type OTHER

Dosage of D-2HG in the urine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Sanson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marc Sanson, MD, PhD

Role: CONTACT

[email protected]
+331 42 16 03 91

Facility Contacts

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Marc Sanson, MD, PhD

Role: primary

+331 42 16 03 91

Other Identifiers

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P120141

Identifier Type: -

Identifier Source: org_study_id