NCT05464992

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
129mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Dec 2022Dec 2036

First Submitted

Initial submission to the registry

July 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2036

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

14 years

First QC Date

July 12, 2022

Last Update Submit

January 29, 2026

Conditions

GliomaBrain Metastases

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • 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

  • 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

Study Arms (1)

Patients with glioma or brain metastases

OTHER
Other: Additional CEST sequences during PET/MRI exam

Interventions

Additional CEST sequences during PET/MRI examOTHER

CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare

Patients with glioma or brain metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France Institut de cancérologie Strasbourg Europe

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Manon VOEGELIN

CONTACT

(0)368339523promotion-rc@icans.eu

Claire VIT

CONTACT

(0)368339523promotion-rc@icans.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 19, 2022

Study Start

December 28, 2022

Primary Completion (Estimated)

December 28, 2036

Study Completion (Estimated)

December 28, 2036

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

FR(1)