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

ConditionGlioblastoma, IDH-Wildtype
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo DSC-MRI

  • Fluciclovine F18

    Other intervention

    Given IV

  • Gadolinium-Chelate

    Drug

    Receive gadolinium-based contrast agent

  • Magnetic Resonance Spectroscopy

    Procedure/Surgery

    Undergo MR spectroscopy

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From biomarker collection to death due to any cause, assessed up to 6 years
2

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.

Time frame
From biomarker collection until progression by Neurological Assessment in Neuro-Oncology (NANO) criteria or death, assessed up to 6 years

Secondary outcomes

1

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.

Time frame
Within 12 weeks post radiation therapy (XRT)
2

Progression-free survival (PFS)

Time frame
From surgery to the earlier of progression or death due to any cause, assessed up to 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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