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Trial Title: Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial

NCT ID: NCT06319027

Condition: Glioblastoma, IDH-Wildtype

Conditions: Official terms:
Glioblastoma
Chelating Agents

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Description: Undergo DSC-MRI
Arm group label: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)

Other name: DSC

Other name: DSC-MRI

Other name: Dynamic Susceptibility Contrast-Enhanced MRI

Other name: DYNAMIC SUSCEPTIBILITY-CONTRAST MRI

Intervention type: Other
Intervention name: Fluciclovine F18
Description: Given IV
Arm group label: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)

Other name: (18F)Fluciclovine

Other name: (18F)GE-148

Other name: 18F-Fluciclovine

Other name: [18F]FACBC

Other name: Anti-(18f)FABC

Other name: Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid

Other name: Anti-[18F] FACBC

Other name: Axumin

Other name: Fluciclovine (18F)

Other name: FLUCICLOVINE F-18

Other name: GE-148 (18F)

Other name: GE-148 F-18

Intervention type: Drug
Intervention name: Gadolinium-Chelate
Description: Receive gadolinium-based contrast agent
Arm group label: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)

Other name: Gadolinium Coordination Complex

Other name: Gadolinium-based Contrast Agent

Other name: Gadolinium-Chelant Complex

Intervention type: Procedure
Intervention name: Magnetic Resonance Spectroscopy
Description: Undergo MR spectroscopy
Arm group label: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)

Other name: NMR Spectroscopy

Other name: NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY

Other name: Spectroscopy, MR

Other name: Spectroscopy, NMR

Other name: Spectroscopy, Nuclear Magnetic Resonance

Intervention type: Procedure
Intervention name: Positron Emission Tomography
Description: Undergo PET scan
Arm group label: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)

Other name: Medical Imaging, Positron Emission Tomography

Other name: PET

Other name: PET Scan

Other name: Positron emission tomography (procedure)

Other name: Positron Emission Tomography Scan

Other name: Positron-Emission Tomography

Other name: proton magnetic resonance spectroscopic imaging

Other name: PT

Summary: This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.

Detailed description: PRIMARY OBJECTIVE: I. For each biomarker (dynamic susceptibility contrast-enhanced MR Imaging, fluciclovine F18 [18F-fluciclovine] PET, MR spectroscopy), to evaluate whether the biomarker can stratify patients with newly diagnosed glioblastoma (GBM) that have progressive enhancement within 12 weeks post-radiation therapy (XRT) into risk groups based on overall survival. SECONDARY OBJECTIVES: I. To evaluate whether each biomarker (dynamic susceptibility contrast-enhanced MR Imaging, 18F-fluciclovine PET, MR spectroscopy) can predict final determination of pseudo-progression (PsP) versus (vs.) true progression on follow-up MR imaging as evaluated by a semi-automated central reading process and by institutional radiologist readings. II. To evaluate whether a prediction model that incorporates multiple biomarkers can discriminate patients with progressive enhancement within 12 weeks post-XRT into high and low risk groups for overall survival. III. To evaluate whether clinical and imaging biomarkers are predictive of overall and progression-free survival in patients who do not show progressive enhancement within 12 weeks post-XRT. EXPLORATORY OBJECTIVE: I. To determine how different methods of defining PsP vs. true progression on imaging relate to patient survival. OUTLINE: Patients receive a gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks after completion of standard of care (SOC) radiation therapy. Patients with evidence of disease progression then undergo MR spectroscopy or receive fluciclovine F18 intravenously (IV) and undergo PET scan within 12 weeks of SOC radiation therapy completion. After completion of study intervention, patients are followed up every 8 weeks for 1 year followed by every 12 weeks for 5 years.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Wisconsin Carbone Cancer Center - University Hospital

Address:
City: Madison
Zip: 53792
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-622-8922
Email: clinicaltrials@cancer.wisc.edu

Investigator:
Last name: Michael Veronesi
Email: Principal Investigator

Start date: April 11, 2024

Completion date: May 31, 2027

Lead sponsor:
Agency: ECOG-ACRIN Cancer Research Group
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Eastern Cooperative Oncology Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06319027

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