Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06319027

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

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-06

100

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

Sponsors

E

ECOG-ACRIN Cancer Research Group

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be 18 years of age or older.
  • Karnofsky Performance Status must be 60% or higher.
  • Newly diagnosed glioblastoma (IDH wild type) confirmed by pathology based on WHO 2021 criteria.
  • Planning to receive standard-of-care treatment for newly diagnosed glioblastoma.
  • Completed MRI before diagnostic surgery for glioblastoma with images available for upload.
  • Diagnostic surgery for glioblastoma performed within 7 weeks before registration.
  • MGMT methylation status ordered at registration.
  • Post-operative MRI completed within 3 weeks after diagnostic surgery with images available for upload.
  • No contraindications to MRI or gadolinium-based contrast agents.
  • No allergies to agents used in non-standard imaging (18F-fluciclovine, MR contrast).
  • Not pregnant or breastfeeding; women of childbearing potential must have a pregnancy test within 14 days before registration.
  • Able to understand and willing to sign informed consent; patients with impaired decision-making capacity with legal representative or caregiver consent are eligible.
  • Patients with prior or concurrent malignancy that does not interfere with safety or efficacy assessments are eligible.
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding.
  • Allergies to gadolinium-based contrast agents or 18F-fluciclovine.
  • Contraindications to MRI or inability to tolerate MRI procedures.
  • Not meeting performance status of 60% or higher on Karnofsky scale.
  • Lack of pathological confirmation of IDH wild type glioblastoma.
  • Inability or unwillingness to provide informed consent or no legal representative available if decision-making capacity is impaired.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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