GliomaGlioCESTNCT05464992
Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
A study testing Additional CEST sequences during PET/MRI exam in people with Glioma and Brain Metastases, run by Centre Paul Strauss at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Brain Metastases
- What is being tested?
- Additional CEST sequences during PET/MRI exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2022to 28 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
France Institut de cancérologie Strasbourg Europe
Strasbourg
Manon VOEGELIN, promotion-rc@icans.eu
Izzie-Jacques NAMER, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Glioma, Brain Metastases
- Being tested
- Additional CEST sequences during PET/MRI exam
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional CEST sequences during PET/MRI examOther
CE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare
| Study group | Role | What they receive |
|---|---|---|
| Patients with glioma or brain metastases | Other | Not described Receives: Other: Additional CEST sequences during PET/MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, up to 14 years
Secondary outcomes (4)
Correlate intratissular pH mapping and location of recurrence
Measured: through study follow-up, up to 10 years
Correlate average pH of the tumor and histopathology
Measured: through study follow-up, up to 10 years
Correlate average pH of the tumor and Disease-Free Survival (DFS)
Measured: through study follow-up, up to 10 years
Correlate average pH of the tumor and Overall survival (OS)
Measured: through study follow-up, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start28 Dec 2022
- Primary completion28 Dec 2036 (estimated)
- Study completion28 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464992
- Sponsor's protocol ID
- 2022-005
- Other IDs
- 2022-A00910-43
- Acronym
- GlioCEST
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2022
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI
- ClinicalTrials.gov ID
- NCT05464992
- Acronym / sponsor ID
- GlioCEST / 2022-005
- Conditions
- Glioma, Brain Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 28 Dec 2036 (estimated)
- Study completion
- 28 Dec 2036 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with glioma or brain metastases | Other | Other: Additional CEST sequences during PET/MRI exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional CEST sequences during PET/MRI examCE-Marked Advanced Technology Software Modules (ATSM) for Magnetic Resonance Imaging from General Electric Healthcare | Other | Patients with glioma or brain metastases |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional CEST sequences during PET/MRI exam in people with Glioma and Brain Metastases, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon VOEGELIN ((0)368339523 ext. 33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.