GlioblastomaPhase 3NCT06448286
PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma
A Phase 3 study testing Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Contrast-enhanced Magnetic Resonance Imaging and Magnetic Resonance Imaging in people with Glioblastoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Contrast-enhanced Magnetic Resonance Imaging and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2031
- Phase
- Phase 3
- 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
- Male or female ≥ 18 years of age
- Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Male or female < 18 years of age
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Not medically cleared for surgery
- Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Kunal S. Patel, 310-825-5111, kunalpatel@mednet.ucla.edu
Kunal S. Patel
About this study
Official title: PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of glioblastoma.
SECONDARY OBJECTIVE:
- To find surgical and adjuvant therapies to treat infiltrating glioblastoma cells.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide orally (PO) for 6 weeks. Additionally, patients undergo MRI during follow up.
GROUP II: Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.
After completion of study treatment, patients are followed up at months 3, 6, 12, and 24.
- Conditions
- Glioblastoma
- Being tested
- Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Contrast-enhanced Magnetic Resonance Imaging, Magnetic Resonance Imaging, Radiation Therapy, Surgical Procedure
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical Exchange Saturation Transfer Magnetic Resonance ImagingProcedure or surgery
Also called Chemical Exchange Saturation Transfer MRI
Undergo CEST MRI
Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery
Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast
Undergo contrast-enhanced MRI
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo standard of care radiation therapy
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgical resection
TemozolomideDrug
Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard of care surgical resection) | Active comparator | Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up. Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Procedure: Surgical Procedure; Drug: Temozolomide |
| Group II (CEST MRI based surgical resection) | Experimental | Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up. Receives: Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Procedure: Surgical Procedure; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Multivariate cox and log rank tests will be used to compare progression free survival.
Measured: Up to 2 years
Secondary outcomes (3)
Overall survival
Multivariate cox and log rank tests will be used to compare overall survival.
Measured: Up to 2 years
Surgical complication rate
Independent sample Chi-squared tests will be used to compare differences in surgical complication rate.
Measured: Up to 2 years
Quality of life: Karnofsky Performance Status
Independent sample Chi-squared tests will be used to compare differences in post-operative Karnofsky performance scale changes. The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kunal S Patel, MD, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448286
- Sponsor's protocol ID
- 23-001605
- Other IDs
- NCI-2024-01961
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma
- ClinicalTrials.gov ID
- NCT06448286
- Acronym / sponsor ID
- 23-001605
- Conditions
- Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 7 Jun 2024 (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.
This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.
Detailed description
PRIMARY OBJECTIVE:
- To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of glioblastoma.
SECONDARY OBJECTIVE:
- To find surgical and adjuvant therapies to treat infiltrating glioblastoma cells.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide orally (PO) for 6 weeks. Additionally, patients undergo MRI during follow up.
GROUP II: Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.
After completion of study treatment, patients are followed up at months 3, 6, 12, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (standard of care surgical resection) | Active comparator | Procedure: Contrast-enhanced Magnetic Resonance Imaging, Procedure: Magnetic Resonance Imaging, Radiation: Radiation Therapy, Procedure: Surgical Procedure, Drug: TemozolomidePatients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up. |
| Group II (CEST MRI based surgical resection) | Experimental | Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Procedure: Magnetic Resonance Imaging, Radiation: Radiation Therapy, Procedure: Surgical Procedure, Drug: TemozolomidePatients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 years of age
- Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (4 listed)
- Male or female < 18 years of age
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Not medically cleared for surgery
- Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)
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 |
|---|---|---|
| Chemical Exchange Saturation Transfer Magnetic Resonance ImagingAlso: Chemical Exchange Saturation Transfer MRIUndergo CEST MRI | Procedure or surgery | Group II (CEST MRI based surgical resection) |
| Contrast-enhanced Magnetic Resonance ImagingAlso: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With ContrastUndergo contrast-enhanced MRI | Procedure or surgery | Group I (standard of care surgical resection) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Group I (standard of care surgical resection), Group II (CEST MRI based surgical resection) |
| Radiation TherapyAlso: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, IrradiateUndergo standard of care radiation therapy | Radiation | Group I (standard of care surgical resection), Group II (CEST MRI based surgical resection) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo surgical resection | Procedure or surgery | Group I (standard of care surgical resection), Group II (CEST MRI based surgical resection) |
| TemozolomideAlso: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831Given PO | Drug | Group I (standard of care surgical resection), Group II (CEST MRI based surgical resection) |
Primary outcome
Progression free survival
Time frame: Up to 2 years
Multivariate cox and log rank tests will be used to compare progression free survival.
3 secondary outcomes
Overall survival
Time frame: Up to 2 years
Surgical complication rate
Time frame: Up to 2 years
Quality of life: Karnofsky Performance Status
Time frame: Up to 2 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 7 Jul 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.
Kunal S Patel, MD principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Contrast-enhanced Magnetic Resonance Imaging and Magnetic Resonance Imaging in people with Glioblastoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jul 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kunal Patel, MD (310-825-5111, KunalPatel@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Up to 2 years). 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 7 Jul 2026.