- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05464992
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI (GlioCEST)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manon VOEGELIN
- Phone Number: 33 (0)368339523
- Email: promotion-rc@icans.eu
Study Contact Backup
- Name: Claire VIT
- Phone Number: 33 (0)368339523
- Email: promotion-rc@icans.eu
Study Locations
-
-
-
Strasbourg, France
- Recruiting
- France Institut de cancérologie Strasbourg Europe
-
Contact:
- Manon VOEGELIN
- Email: promotion-rc@icans.eu
-
Principal Investigator:
- Izzie-Jacques NAMER, MD, PhD
-
Sub-Investigator:
- Caroline BUND, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with glioma or brain metastases
|
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, up to 14 years
|
|
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
|
through study completion, up to 14 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlate intratissular pH mapping and location of recurrence
Time Frame: through study follow-up, up to 10 years
|
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
|
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
|
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
|
through study follow-up, up to 10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioma
- Brain Neoplasms
Other Study ID Numbers
- 2022-005
- 2022-A00910-43 (Other Identifier: ID-RCB Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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