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Recruiting NCT05464992

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

No phase Interventional Glioma Brain Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Additional CEST sequences during PET/MRI exam.
Who it may be relevant to
Registry conditions: Glioma, Brain Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • France Institut de cancérologie Strasbourg Europe — Strasbourg

Identifiers

NCT: NCT05464992 · 2022-005 · 2022-A00910-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗