We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05464992
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : January 5, 2023
Sponsor:
Information provided by (Responsible Party):
Institut de cancérologie Strasbourg Europe

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Glioma Brain Metastases Other: Additional CEST sequences during PET/MRI exam Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
Actual Study Start Date : December 28, 2022
Estimated Primary Completion Date : December 28, 2036
Estimated Study Completion Date : December 28, 2036

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Patients with glioma or brain metastases Other: Additional CEST sequences during PET/MRI exam
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases [ Time Frame: through study completion, up to 14 years ]
    Evaluation at the cerebral level on the acquisition images of residual volume in MRI

  2. Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases [ Time Frame: through study completion, up to 14 years ]
    Evaluation at the cerebral level on the acquisition images of tumoral metabolic activity in PET


Secondary Outcome Measures :
  1. Correlate intratissular pH mapping and location of recurrence [ Time Frame: through study follow-up, up to 10 years ]
  2. Correlate average pH of the tumor and histopathology [ Time Frame: through study follow-up, up to 10 years ]
  3. Correlate average pH of the tumor and Disease-Free Survival (DFS) [ Time Frame: through study follow-up, up to 10 years ]
  4. Correlate average pH of the tumor and Overall survival (OS) [ Time Frame: through study follow-up, up to 10 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05464992


Contacts
Layout table for location contacts
Contact: Manon VOEGELIN (0)368339523 ext 33 promotion-rc@icans.eu
Contact: Claire VIT (0)368339523 ext 33 promotion-rc@icans.eu

Locations
Layout table for location information
France
France Institut de cancérologie Strasbourg Europe Recruiting
Strasbourg, France
Contact: Manon VOEGELIN       promotion-rc@icans.eu   
Principal Investigator: Izzie-Jacques NAMER, MD, PhD         
Sub-Investigator: Caroline BUND, MD, PhD         
Sponsors and Collaborators
Institut de cancérologie Strasbourg Europe
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier: NCT05464992    
Other Study ID Numbers: 2022-005
2022-A00910-43 ( Other Identifier: ID-RCB Number )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases