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Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI (GlioCEST)

Primary Purpose

Glioma, Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional CEST sequences during PET/MRI exam
Sponsored by
Institut de cancérologie Strasbourg Europe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted to the Nuclear Medicine and Molecular Imaging department of ICANS (Institut de cancérologie strasbourg Europe) for a PET/MRI exam dedicated to:

  • Preoperative evaluation of a cerebral expansion lesion
  • Evaluation of glioma recurrences
  • Evaluation of brain metastases
  • Evaluation of recurrence of metastases

Exclusion Criteria:

  • Contraindication to the realization of an MRI
  • Minor or patients placed under guardianship or supervision
  • Patients deprived of liberty
  • Patients placed under judicial protection
  • Patients that are not able to express their consent
  • Pregnant and breastfeeding women

Sites / Locations

  • France Institut de cancérologie Strasbourg EuropeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with glioma or brain metastases

Arm Description

Outcomes

Primary Outcome Measures

Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases
Evaluation at the cerebral level on the acquisition images of residual volume in MRI
Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases
Evaluation at the cerebral level on the acquisition images of tumoral metabolic activity in PET

Secondary Outcome Measures

Correlate intratissular pH mapping and location of recurrence
Correlate average pH of the tumor and histopathology
Correlate average pH of the tumor and Disease-Free Survival (DFS)
Correlate average pH of the tumor and Overall survival (OS)

Full Information

First Posted
July 12, 2022
Last Updated
January 3, 2023
Sponsor
Institut de cancérologie Strasbourg Europe
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1. Study Identification

Unique Protocol Identification Number
NCT05464992
Brief Title
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
Acronym
GlioCEST
Official Title
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
December 28, 2036 (Anticipated)
Study Completion Date
December 28, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de cancérologie Strasbourg Europe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Standard Magnetic Resonance Imaging (MRI) is based on the excitation of hydrogen nuclei that are presents in water molecules, which abundance in human body allows for obtention of superior contrast. However, assessing the presence of other molecules than water in tissues is also of great clinical interest to probe metabolites related to physiological body function and pathological conditions. Chemical exchange saturation transfer (CEST) allow to overcome some limitations of proton magnetic resonance spectroscopy (1H-MRS) by exploiting chemical properties of the targeted molecule through a continuous process of re-saturation and exchange, and thus detecting it with increased sensitivity, from two orders of magnitude. Moreover, CEST technique is based on imaging sequences and can therefore benefit from well-known fast acquisition strategies, as well as improved spatial resolution.
Detailed Description
For this study the investigators propose to include an additional CEST sequence in standard PET/MRI exam in order to obtain a cartography with biochemical informations from tissues in patients with glioma or brain metastases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Metastases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with glioma or brain metastases
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Additional CEST sequences during PET/MRI exam
Intervention Description
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare
Primary Outcome Measure Information:
Title
Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases
Description
Evaluation at the cerebral level on the acquisition images of residual volume in MRI
Time Frame
through study completion, up to 14 years
Title
Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases
Description
Evaluation at the cerebral level on the acquisition images of tumoral metabolic activity in PET
Time Frame
through study completion, up to 14 years
Secondary Outcome Measure Information:
Title
Correlate intratissular pH mapping and location of recurrence
Time Frame
through study follow-up, up to 10 years
Title
Correlate average pH of the tumor and histopathology
Time Frame
through study follow-up, up to 10 years
Title
Correlate average pH of the tumor and Disease-Free Survival (DFS)
Time Frame
through study follow-up, up to 10 years
Title
Correlate average pH of the tumor and Overall survival (OS)
Time Frame
through study follow-up, up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to the Nuclear Medicine and Molecular Imaging department of ICANS (Institut de cancérologie strasbourg Europe) for a PET/MRI exam dedicated to: Preoperative evaluation of a cerebral expansion lesion Evaluation of glioma recurrences Evaluation of brain metastases Evaluation of recurrence of metastases Exclusion Criteria: Contraindication to the realization of an MRI Minor or patients placed under guardianship or supervision Patients deprived of liberty Patients placed under judicial protection Patients that are not able to express their consent Pregnant and breastfeeding women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon VOEGELIN
Phone
(0)368339523
Ext
33
Email
promotion-rc@icans.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Claire VIT
Phone
(0)368339523
Ext
33
Email
promotion-rc@icans.eu
Facility Information:
Facility Name
France Institut de cancérologie Strasbourg Europe
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon VOEGELIN
Email
promotion-rc@icans.eu
First Name & Middle Initial & Last Name & Degree
Izzie-Jacques NAMER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Caroline BUND, MD, PhD

12. IPD Sharing Statement

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Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI

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