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

Glioma Clinical Trial

— GlioCEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464992
• Other study ID #: 2022-005
• Secondary ID: 2022-A00910-43
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 28, 2036

Study information

• Verified date: January 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: (0)368339523
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 28, 2036
• Est. primary completion date: December 28, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Glioma

Intervention

Other:
• Additional CEST sequences during PET/MRI exam
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare

Locations

Country	Name	City	State
France	France Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, up to 14 years
Primary	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	through study completion, up to 14 years
Secondary	Correlate intratissular pH mapping and location of recurrence		through study follow-up, up to 10 years
Secondary	Correlate average pH of the tumor and histopathology		through study follow-up, up to 10 years
Secondary	Correlate average pH of the tumor and Disease-Free Survival (DFS)		through study follow-up, up to 10 years
Secondary	Correlate average pH of the tumor and Overall survival (OS)		through study follow-up, up to 10 years