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

Not Applicable

Recruiting

• Conditions: Brain Metastases; Glioma
• Interventions: Other: Additional CEST sequences during PET/MRI exam

• Registration Number: NCT05464992
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

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 Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Start: 2022-12-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05
• Primary Completion: 2036-12-28
• Study Completion: 2036-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with glioma or brain metastases	Additional CEST sequences during PET/MRI exam	-

Primary Outcome Measures

Name	Time	Method
Obtention, from a set of brain PET-MRI images, of an intratissular pH mapping in patients with glioma or brain metastases	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

Name	Time	Method
Correlate average pH of the tumor and Disease-Free Survival (DFS)	through study follow-up, up to 10 years
Correlate average pH of the tumor and Overall survival (OS)	through study follow-up, up to 10 years
Correlate intratissular pH mapping and location of recurrence	through study follow-up, up to 10 years
Correlate average pH of the tumor and histopathology	through study follow-up, up to 10 years

Trial Locations

Locations (1)

France Institut de cancérologie Strasbourg Europe; 🇫🇷 Strasbourg, France