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

NCT06448286 | Not Yet Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: 23-001605NCI-2024-01961
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Multivariate cox and log rank tests will be used to compare progression free survival.

  Up to 2 years

Secondary Outcomes (3)

• Overall survival

  Up to 2 years

• Surgical complication rate

  Up to 2 years

• Quality of life

  Up to 2 years

Study Arms (2)

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.

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.

Procedure: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Procedure: Surgical Procedure; Drug: Temozolomide

Interventions

Contrast-enhanced Magnetic Resonance Imaging PROCEDURE

Undergo contrast-enhanced MRI

Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI, MRI With Contrast

Group I (standard of care surgical resection)

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging PROCEDURE

Undergo CEST MRI

Also known as: Chemical Exchange Saturation Transfer MRI

Group II (CEST MRI based surgical resection)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Group I (standard of care surgical resection); Group II (CEST MRI based surgical resection)

Radiation Therapy RADIATION

Undergo standard of care radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Group I (standard of care surgical resection); Group II (CEST MRI based surgical resection)

Surgical Procedure PROCEDURE

Undergo surgical resection

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Group I (standard of care surgical resection); Group II (CEST MRI based surgical resection)

Temozolomide DRUG

Given PO

Also known as: 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

Group I (standard of care surgical resection); Group II (CEST MRI based surgical resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Magnetic Resonance Spectroscopy; Contrast Media; Radiotherapy; Radiation; Surgical Procedures, Operative; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Therapeutics; Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kunal S Patel, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunal Patel, MD

CONTACT

310-825-5111; KunalPatel@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, investigators and research staff will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2025-06

Locations

US (1)