Menu
Not yet recruiting NCT06448286

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

Phase III Interventional Glioblastoma

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: Chemical Exchange Saturation Transfer Magnetic Resonance Imaging, Contrast-enhanced Magnetic Resonance Imaging, Magnetic Resonance Imaging, Radiation Therapy.
Who it may be relevant to
Registry conditions: Glioblastoma. 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
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma

Overview

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.

Interventions

  • Procedure Chemical Exchange Saturation Transfer Magnetic Resonance Imaging
    Undergo CEST MRI
  • Procedure Contrast-enhanced Magnetic Resonance Imaging
    Undergo contrast-enhanced MRI
  • Procedure Magnetic Resonance Imaging
    Undergo MRI
  • Radiation Radiation Therapy
    Undergo standard of care radiation therapy
  • Procedure Surgical Procedure
    Undergo surgical resection
  • Drug Temozolomide
    Given PO

Primary outcome measures

  • Progression free survival [Time frame: Up to 2 years]
Secondary outcome measures (3)
  • 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]

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)

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06448286 · 23-001605 · NCI-2024-01961

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗