PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma

NCT ID: NCT06448286

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-06-01

Brief 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. 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:

I. To assess the efficacy of potential of hydrogen (pH) sensitive MRI based resections of glioblastoma.

SECONDARY OBJECTIVE:

I. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I (standard of care surgical resection)

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.

Group Type: ACTIVE_COMPARATOR

Contrast-enhanced Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo contrast-enhanced MRI

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Radiation Therapy

Intervention Type: RADIATION

Undergo standard of care radiation therapy

Surgical Procedure

Intervention Type: PROCEDURE

Undergo surgical resection

Temozolomide

Intervention Type: DRUG

Given PO

Group II (CEST MRI based surgical resection)

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.

Group Type: EXPERIMENTAL

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo CEST MRI

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Radiation Therapy

Intervention Type: RADIATION

Undergo standard of care radiation therapy

Surgical Procedure

Intervention Type: PROCEDURE

Undergo surgical resection

Temozolomide

Intervention Type: DRUG

Given PO

Interventions

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Undergo CEST MRI

Intervention Type: PROCEDURE

Contrast-enhanced Magnetic Resonance Imaging

Undergo contrast-enhanced MRI

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Radiation Therapy

Undergo standard of care radiation therapy

Intervention Type: RADIATION

Surgical Procedure

Undergo surgical resection

Intervention Type: PROCEDURE

Temozolomide

Given PO

Intervention Type: DRUG

Other Intervention Names

Chemical Exchange Saturation Transfer MRI; CONTRAST ENHANCED MRI; Contrast-enhanced MRI; MRI With Contrast; Magnetic Resonance; Magnetic Resonance Imaging (MRI); Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; MRIs; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; sMRI; Structural MRI; Cancer Radiotherapy; Energy Type; ENERGY_TYPE; Irradiate; Irradiated; Irradiation; Radiation; Radiation Therapy, NOS; Radiotherapeutics; Radiotherapy; RT; Therapy, Radiation; Operation; Surgery; Surgery Type; Surgery, NOS; Surgical; Surgical Intervention; Surgical Interventions; Surgical Procedures; Type of Surgery; CCRG-81045; Gliotem; Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-; M & B 39831; M and B 39831; Methazolastone; RP-46161; SCH 52365; Temcad; Temizole; Temodal; Temodar; Temomedac; TMZ

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kunal S Patel, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Kunal Patel, MD

Role: CONTACT

KunalPatel@mednet.ucla.edu

310-825-5111

Facility Contacts

Kunal S. Patel

Role: primary

kunalpatel@mednet.ucla.edu

310-825-5111

Other Identifiers

NCI-2024-01961

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-001605

Identifier Type: -

Identifier Source: org_study_id