Glioblastoma Accelerated Biomarkers Learning Environment Trial

What is the Purpose of this Study?

The purpose of this study is to identify new biological markers (specific biological features) associated with scans of a brain tumor that will help doctors predict how tumors might develop and affect the health of patients. The usual imaging technique used to assess for brain tumor progression is (mostly) magnetic resonance imaging (MRI). Researchers want to determine whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of brain tumors. Specifically, the study aims to understand the meaning of changes in MRI scans after treatment, as well as whether the appearance of some of these changes may reflect a progressing tumor or may be due to treatment. Participants will undergo the usual approach of combination chemotherapy and radiation treatment, with MRIs over the course of treatment. They will also undergo DSC-MRI scans (a special type of MRI that shows how fluids flow through the brain). Some participants may also be scheduled for another imaging test called a positron emission tomography (PET) scan, which includes injection of 18F-fluciclovine. 18F-fluciclovine is approved by the U.S. Food and Drug Administration (FDA) to be used in imaging for prostate cancer, but its use in imaging for glioblastoma is experimental; previous studies have used it successfully in imaging for gliomas (another type of brain tumor).

Eligibility

* Patient must be ≥ 18 years of age.
* Patient must have a Karnofsky Performance Status ≥ 60%.
* Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.
* Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.

Inclusion Criteria:

* Patient must be ≥ 18 years of age.
* Patient must have a Karnofsky Performance Status ≥ 60%.
* Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.
* Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.
* Patient must have completed an MRI prior to the diagnostic surgery for GBM and have images available for upload into Transfer of Images and Data (TRIAD).
* Patient must have diagnostic surgery for GBM within 7 weeks prior to registration.
* Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration.
* Patient must have a post-operative (op) MRI completed within 3 weeks after diagnostic surgery for GBM and have images available for upload into TRIAD.
* Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging.
* Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast).
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the interventions being used.
* All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
* A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Show less

Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan

More about this Clinical Trial

What is the full name of this clinical trial?

EAF223: Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial

Study Details

Disease Type/Condition

Brain and Nervous System

Principal Investigator

Rudnick, Jeremy

Co-Investigators

Adam Mamelak, Alessandro D'Agnolo, Amin Mirhadi, Behrooz Hakimian, Chirag Patil, Jethro Hu, John Yu, Louise Thomson, Ray Chu, Stephen Shiao

Age Group

Adult

Phase

IRB Number

STUDY00003641

ClinicalTrials.gov ID

NCT06319027

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Shannon Cyhan

Shannon.Cyhan@cshs.org