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

Part of paid clinical trials in Los Angeles, California.

Sponsor
ECOG-ACRIN Cancer Research Group
Study ID
NCT06319027
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging — PROCEDURE
    Undergo DSC-MRI
  • Fluciclovine F18 — OTHER
    Given IV
  • Gadolinium-Chelate — DRUG
    Receive gadolinium-based contrast agent
  • Magnetic Resonance Spectroscopy — PROCEDURE
    Undergo MR spectroscopy
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan

Study Details

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.

Key Dates

Start date
Apr 11, 2024
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)
    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.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From biomarker collection to death due to any cause, assessed up to 6 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Site Public Contact
[email protected]
310-423-2133
Jeremy D. Rudnick (PRINCIPAL_INVESTIGATOR)
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Site Public Contact
904-202-7468
Robert Cavaliere (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Site Public Contact
[email protected]
800-679-0775
Joaquim Farinhas (PRINCIPAL_INVESTIGATOR)
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Site Public Contact
[email protected]
800-865-1125
Michelle M. Kim (PRINCIPAL_INVESTIGATOR)
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203
Site Public Contact
800-804-9376
Ashley L. Sumrall (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Site Public Contact
888-275-3853
Annick Desjardins (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Site Public Contact
336-713-6771
Marc Benayoun (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Site Public Contact
401-444-1488
Eric T. Wong (PRINCIPAL_INVESTIGATOR)
Edwards Comprehensive Cancer CenterHuntingtonWest Virginia25701
Site Public Contact
[email protected]
304-399-6566
Toni O. Pacioles (PRINCIPAL_INVESTIGATOR)
West Virginia University HealthcareMorgantownWest Virginia26506
Site Public Contact
[email protected]
304-293-7374
Sonikpreet Aulakh (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718
Site Public Contact
[email protected]
800-622-8922
Michael Veronesi (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Site Public Contact
[email protected]
800-622-8922
Michael Veronesi (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CABaptist MD Anderson Cancer Center· Jacksonville, FLMoffitt Cancer Center· Tampa, FLUniversity of Michigan Rogel Cancer Center· Ann Arbor, MICarolinas Medical Center/Levine Cancer Institute· Charlotte, NCDuke University Medical Center· Durham, NC

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