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

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.

Interventions

• Chemical Exchange Saturation Transfer Magnetic Resonance Imaging · PROCEDURE

  Undergo CEST MRI

• Contrast-enhanced Magnetic Resonance Imaging · PROCEDURE

  Undergo contrast-enhanced MRI

• Magnetic Resonance Imaging · PROCEDURE

  Undergo MRI

• Radiation Therapy · RADIATION

  Undergo standard of care radiation therapy

• Surgical Procedure · PROCEDURE

  Undergo surgical resection

• Temozolomide · DRUG

  Given PO

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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)

Sites (1)

• UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California