Multimodal Imaging of Hypoxia in Gliomas (GLIOXYMAGE)
Primary Purpose
Glioma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI Oxygen Saturation Map
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma focused on measuring MRI, Hypoxia, O2 saturation, FMISO PET, Glioma
Eligibility Criteria
Inclusion Criteria:
- Adult patient (> 18 years-old)
- Patient with a diffuse glioma (astrocytoma or oligodendroglioma or glioblastoma)
- Karnofsky index ≥ 70%
- Patient able to understand and sign the consent or accompanied by a trusted person who can do so
- Normal blood test with results: neutrophil ≥ 1500 cells / μl, platelets ≥ 100,000 μl, serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x upper normal limit (UNL), creatine ≤ 1.5 x UNL
- Patient affiliated to a social security
Exclusion Criteria:
- Patient with contraindications to surgery
Sites / Locations
- CHU de Caen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SatO2
Arm Description
Outcomes
Primary Outcome Measures
MRI tissue oxygenation map (SatO2-MRI) validation
Validation of SatO2-MRI as a reliable imaging method to detect hypoxic regions, in comparison with FMISO PET. This will mainly be done by measuring spatial correlation of hypoxic regions obtained by the two imaging modalities.
Secondary Outcome Measures
Comparison with pathologic studies
To correlate imaging biomarkers with more conventional approaches on tissue slices (immunohistochemistry HIF1 / HIF2 / CD34)
Full Information
NCT ID
NCT03716986
First Posted
October 12, 2018
Last Updated
October 22, 2018
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT03716986
Brief Title
Multimodal Imaging of Hypoxia in Gliomas
Acronym
GLIOXYMAGE
Official Title
Multimodal Imaging of Hypoxia in Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg).
Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI.
This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO.
The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET.
The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2).
This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
MRI, Hypoxia, O2 saturation, FMISO PET, Glioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SatO2
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI Oxygen Saturation Map
Intervention Description
Calculation of the oxygen saturation map of gliomas cases
Primary Outcome Measure Information:
Title
MRI tissue oxygenation map (SatO2-MRI) validation
Description
Validation of SatO2-MRI as a reliable imaging method to detect hypoxic regions, in comparison with FMISO PET. This will mainly be done by measuring spatial correlation of hypoxic regions obtained by the two imaging modalities.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Comparison with pathologic studies
Description
To correlate imaging biomarkers with more conventional approaches on tissue slices (immunohistochemistry HIF1 / HIF2 / CD34)
Time Frame
7 to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (> 18 years-old)
Patient with a diffuse glioma (astrocytoma or oligodendroglioma or glioblastoma)
Karnofsky index ≥ 70%
Patient able to understand and sign the consent or accompanied by a trusted person who can do so
Normal blood test with results: neutrophil ≥ 1500 cells / μl, platelets ≥ 100,000 μl, serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.5 x upper normal limit (UNL), creatine ≤ 1.5 x UNL
Patient affiliated to a social security
Exclusion Criteria:
- Patient with contraindications to surgery
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hassanein BERRO, MD
Phone
+33644664406
Email
dh@berro.net
12. IPD Sharing Statement
Learn more about this trial
Multimodal Imaging of Hypoxia in Gliomas
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