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