Glioblastoma, IDH-WildtypePhase 2GABLENCT06319027
Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
A Phase 2 study testing Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Fluciclovine F18 and Gadolinium-Chelate in people with Glioblastoma, IDH-Wildtype, run by ECOG-ACRIN Cancer Research Group at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, IDH-Wildtype
- What is being tested?
- Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Fluciclovine F18 and Gadolinium-Chelate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- 11 Apr 2024to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 16 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Michelle M. Kim
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Hui-Kuo G. Shu
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Jonathan E. McConathy
- Suspended
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Annick Desjardins
- Recruiting
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Site Public Contact, 304-399-6566, Christina.Cole@chhi.org
Toni O. Pacioles
- Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Site Public Contact, 904-202-7468
Robert Cavaliere
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Jeremy D. Rudnick
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Michael Veronesi
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Michael Veronesi
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Jennifer M. Connelly
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Jennifer M. Connelly
- Recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu
Sonikpreet Aulakh
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Jennifer M. Connelly
- Suspended
Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org
Joaquim Farinhas
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Jennifer M. Connelly
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Marc Benayoun
About this study
Official title: Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Glioblastoma, IDH-Wildtype
- Being tested
- Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Fluciclovine F18, Gadolinium-Chelate, Magnetic Resonance Spectroscopy, Positron Emission Tomography
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DSC, DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRI
Undergo DSC-MRI
Fluciclovine F18Other
Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC
Given IV
Gadolinium-ChelateDrug
Also called Gadolinium Coordination Complex, Gadolinium-based Contrast Agent, Gadolinium-Chelant Complex
Receive gadolinium-based contrast agent
Magnetic Resonance SpectroscopyProcedure or surgery
Also called NMR Spectroscopy, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY, Spectroscopy, MR, Spectroscopy, NMR
Undergo MR spectroscopy
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) | Experimental | Patients receive a gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks after completion of SOC radiation therapy. Patients with evidence of disease progression then undergo MR spectroscopy or receive fluciclovine F18 IV and undergo PET scan within 12 weeks of SOC radiation therapy completion. Receives: Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Other: Fluciclovine F18; Drug: Gadolinium-Chelate; Procedure: Magnetic Resonance Spectroscopy; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Will use a two-sided log-rank test to compare the difference in OS between marker positive and marker negative participants using a significance level of 0.05.
Measured: From biomarker collection to death due to any cause, assessed up to 6 years
Event free survival (EFS)
NANO progression is defined as a ≥ 2 level worsening from baseline or best level of function in at least one domain or worsening to the highest score within ≥1 domain that is felt to be related to underlying tumor progression and not attributable to a comorbid event or change in concurrent medication. Will be based on the conditional power of a two-sided log-rank test for EFS between marker positive and marker negative participants using a significance level of 0.05.
Measured: From biomarker collection until progression by Neurological Assessment in Neuro-Oncology (NANO) criteria or death, assessed up to 6 years
Secondary outcomes (2)
True disease progression and pseudo-progression (PsP)
The T3 MRI will be used to determine whether progressive enhancement seen within 12 weeks post-XRT was true progression or PsP.
Measured: Within 12 weeks post radiation therapy (XRT)
Progression-free survival (PFS)
Measured: From surgery to the earlier of progression or death due to any cause, assessed up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start11 Apr 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma, IDH-WildtypeStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel P Barboriak, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319027
- Sponsor's protocol ID
- EAF223
- Other IDs
- NCI-2023-08557, EAF223, EAF223, U10CA180820
- Acronym
- GABLE
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)
- ClinicalTrials.gov ID
- NCT06319027
- Acronym / sponsor ID
- GABLE / EAF223
- Conditions
- Glioblastoma, IDH-Wildtype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) | Experimental | Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Other: Fluciclovine F18, Drug: Gadolinium-Chelate, Procedure: Magnetic Resonance Spectroscopy, Procedure: Positron Emission TomographyPatients receive a gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks after completion of SOC radiation therapy. Patients with evidence of disease progression then undergo MR spectroscopy or receive fluciclovine F18 IV and undergo PET scan within 12 weeks of SOC radiation therapy completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: DSC, DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRIUndergo DSC-MRI | Procedure or surgery | Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) |
| Fluciclovine F18Also: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBCGiven IV | Other | Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) |
| Gadolinium-ChelateAlso: Gadolinium Coordination Complex, Gadolinium-based Contrast Agent, Gadolinium-Chelant ComplexReceive gadolinium-based contrast agent | Drug | Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) |
| Magnetic Resonance SpectroscopyAlso: NMR Spectroscopy, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY, Spectroscopy, MR, Spectroscopy, NMRUndergo MR spectroscopy | Procedure or surgery | Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET scan | Procedure or surgery | Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy) |
Primary outcome
Overall survival (OS)
Time frame: From biomarker collection to death due to any cause, assessed up to 6 years
Will use a two-sided log-rank test to compare the difference in OS between marker positive and marker negative participants using a significance level of 0.05.
Event free survival (EFS)
Time frame: From biomarker collection until progression by Neurological Assessment in Neuro-Oncology (NANO) criteria or death, assessed up to 6 years
NANO progression is defined as a ≥ 2 level worsening from baseline or best level of function in at least one domain or worsening to the highest score within ≥1 domain that is felt to be related to underlying tumor progression and not attributable to a comorbid event or change in concurrent medication. Will be based on the conditional power of a two-sided log-rank test for EFS between marker positive and marker negative participants using a significance level of 0.05.
2 secondary outcomes
True disease progression and pseudo-progression (PsP)
Time frame: Within 12 weeks post radiation therapy (XRT)
Progression-free survival (PFS)
Time frame: From surgery to the earlier of progression or death due to any cause, assessed up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel P Barboriak principal investigator
ECOG-ACRIN Cancer Research Group
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Fluciclovine F18 and Gadolinium-Chelate in people with Glioblastoma, IDH-Wildtype, run by ECOG-ACRIN Cancer Research Group at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From biomarker collection to death due to any cause, assessed up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.