Improving predictions for brain cancer progression using advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates whether advanced imaging techniques, such as dynamic susceptibility contrast-enhanced MRI, fluciclovine F18 PET, and MR spectroscopy, can provide more accurate assessments of tumor activity in patients with newly diagnosed glioblastoma. The study aims to stratify patients based on overall survival and differentiate between pseudo-progression and true progression of the tumor after standard radiation therapy. By analyzing changes in imaging results, the trial seeks to enhance the understanding of tumor behavior and improve patient management.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Baptist MD Anderson Cancer Center
  Jacksonville, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Daniel P Barboriak — ECOG-ACRIN Cancer Research Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.