Non Invasive Detection of IDH1/2 Mutation in Gliomas (IDASPE)
Primary Purpose
Glioma, IDH1/IDH2 Mutation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spectro-MRI
Dosage of free circulating plasmatic DNA
Dosage of D-2HG in the urine
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma focused on measuring Glioma, IDH1/IDH2 mutation, Spectroscopy MRI, D-2-hydroxyglutarate, Free circulating DNA
Eligibility Criteria
Inclusion criteria
- Affiliation to a social security system
- Patient≥ 18 years old
- Written informed consent
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)
- Evaluable tumoral mass min diameter >2 cm (FLAIR)
- PKPS > 60
Exclusion criteria
- Contra-indication to MRI
- Patient unable to give an written Informed Consent
- Patient under guardianship or deprived of freedom
- For group 2: patient already included in group 1
Sites / Locations
- Groupe Hospitalier Pitié-SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IDH1/IDH2
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02597335
First Posted
April 27, 2015
Last Updated
September 19, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02597335
Brief Title
Non Invasive Detection of IDH1/2 Mutation in Gliomas
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
longitudinal analysis Spectro-MRI overtime (12 months) correlation with radiological evolution and the response to treatment (group 2: 15 patients)
Differentiation of tumor recurrence from radiation induced changes
Confrontation of Spectro-MRI, D-2HG dosages and IDH mutation detection from plasma DNA, and elaboration of a combined score of prediction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, IDH1/IDH2 Mutation
Keywords
Glioma, IDH1/IDH2 mutation, Spectroscopy MRI, D-2-hydroxyglutarate, Free circulating DNA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IDH1/IDH2
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Spectro-MRI
Intervention Description
Spectro-MRI for D-2HG detection
Intervention Type
Other
Intervention Name(s)
Dosage of free circulating plasmatic DNA
Intervention Type
Other
Intervention Name(s)
Dosage of D-2HG in the urine
Primary Outcome Measure Information:
Title
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]
Description
This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]
Description
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
Time Frame
evolution over 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Affiliation to a social security system
Patient≥ 18 years old
Written informed consent
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)
Evaluable tumoral mass min diameter >2 cm (FLAIR)
PKPS > 60
Exclusion criteria
Contra-indication to MRI
Patient unable to give an written Informed Consent
Patient under guardianship or deprived of freedom
For group 2: patient already included in group 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Sanson, MD, PhD
Phone
+331 42 16 03 91
Email
marc.sanson@psl.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Sanson, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Sanson, MD, PhD
Phone
+331 42 16 03 91
12. IPD Sharing Statement
Learn more about this trial
Non Invasive Detection of IDH1/2 Mutation in Gliomas
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