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New treatment option for Glioblastoma, IDH-Wildtype
Official title Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
ClinicalTrials.gov ID: NCT06319027
What this study is testing
What is Gadolinium-Chelate?
Gadolinium-Chelate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma, idh-wildtype.
Also referred to as Gadolinium Coordination Complex, Gadolinium-based Contrast Agent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
See the full eligibility 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...
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Ann Arbor, Michigan, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Providence, Rhode Island, United States
- Huntington, West Virginia, United States
- Morgantown, West Virginia, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Ann Arbor, Michigan, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.