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

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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

Tracking Information
First Submitted Date  ICMJE July 12, 2022
First Posted Date  ICMJE July 19, 2022
Last Update Posted Date January 5, 2023
Actual Study Start Date  ICMJE December 28, 2022
Estimated Primary Completion Date December 28, 2036   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2022)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2022)
  • Correlate intratissular pH mapping and location of recurrence [ Time Frame: through study follow-up, up to 10 years ]
  • Correlate average pH of the tumor and histopathology [ Time Frame: through study follow-up, up to 10 years ]
  • Correlate average pH of the tumor and Disease-Free Survival (DFS) [ Time Frame: through study follow-up, up to 10 years ]
  • Correlate average pH of the tumor and Overall survival (OS) [ Time Frame: through study follow-up, up to 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
Official Title  ICMJE Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Glioma
  • Brain Metastases
Intervention  ICMJE Other: Additional CEST sequences during PET/MRI exam
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare
Study Arms  ICMJE Patients with glioma or brain metastases
Intervention: Other: Additional CEST sequences during PET/MRI exam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2022)		 800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 28, 2036
Estimated Primary Completion Date December 28, 2036   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manon VOEGELIN (0)368339523 ext 33 promotion-rc@icans.eu
Contact: Claire VIT (0)368339523 ext 33 promotion-rc@icans.eu
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05464992
Other Study ID Numbers  ICMJE 2022-005
2022-A00910-43 ( Other Identifier: ID-RCB Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Institut de cancérologie Strasbourg Europe
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut de cancérologie Strasbourg Europe
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut de cancérologie Strasbourg Europe
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP