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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
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Groupe Hospitalier Pitié-Salpêtrière
Paris, France
Start Date
April 1, 2015
Primary Completion Date
April 1, 2018
Completion Date
April 1, 2018
Last Updated
September 20, 2017
40
ESTIMATED participants
Spectro-MRI
RADIATION
Dosage of free circulating plasmatic DNA
OTHER
Dosage of D-2HG in the urine
OTHER
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
NCT06860594
NCT05099003
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05839379