Advanced Imaging Techniques for Glioblastoma
(GABLE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: ECOG-ACRIN Cancer Research Group
Disqualifiers: Pregnancy, Breast-feeding, MRI contraindications, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging and bevacizumab for glioblastoma?
Research shows that using dynamic susceptibility contrast MRI to measure blood volume changes can help predict how well patients with recurrent glioblastoma respond to bevacizumab, a drug that targets blood vessel growth in tumors.
12345Is the treatment generally safe for humans?
The studies focus on the effectiveness of bevacizumab and advanced imaging techniques in treating glioblastoma, but they do not provide specific safety data for these treatments. Bevacizumab has been used in various conditions, suggesting it is generally considered safe, but specific safety details are not provided in these studies.
13567How does this treatment differ from other treatments for glioblastoma?
This treatment uses advanced imaging techniques, like dynamic susceptibility contrast MRI, to monitor blood flow and volume in the brain, which helps predict how well a patient is responding to treatments like bevacizumab. This approach is unique because it provides detailed insights into the tumor's blood supply, potentially allowing for more personalized and effective treatment plans.
12358Eligibility Criteria
This trial is for adults over 18 with newly diagnosed glioblastoma (GBM), confirmed by pathology and who have had surgery within the last 7 weeks. Participants must be in good enough health to perform daily activities (Karnofsky Performance Status ≥ 60%) and plan to receive standard GBM treatment. They should have completed certain MRIs, not be allergic to imaging agents, and able to tolerate MRI procedures.Inclusion Criteria
I had surgery to diagnose my brain tumor less than 7 weeks ago.
I am 18 years old or older.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets specific criteria
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation Therapy
Participants complete standard of care radiation therapy
6 weeks
Imaging Assessment
Participants receive gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks post-radiation therapy. Additional MR spectroscopy or fluciclovine F18 PET scans are conducted if disease progression is evident.
12 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up every 8 weeks for 1 year, then every 12 weeks for 5 years.
6 years
Participant Groups
The study tests if advanced brain scan techniques like Fluciclovine F18 PET scans, Dynamic Susceptibility Contrast-Enhanced MRI, Gadolinium-Chelate enhanced images, and Magnetic Resonance Spectroscopy can more accurately assess tumor activity in patients with new glioblastoma compared to usual MRI methods.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)Experimental Treatment5 Interventions
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin Carbone Cancer Center - University HospitalMadison, WI
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Who Is Running the Clinical Trial?
ECOG-ACRIN Cancer Research GroupLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Prognostic value of relative cerebral blood volume in patients with recurrent glioblastoma multiforme treated with bevacizumab. [2020]The aim of this study was to assess whether the early monitoring of the effects of bevacizumab in patients with recurrent glioblastoma multiforme (GBM) using perfusional dynamic susceptibility contrast (DSC) magnetic resonance imaging (MRI) before and after the beginning of antiangiogenic therapy is predictive of treatment response.
Dynamic susceptibility contrast-enhanced perfusion magnetic resonance (MR) imaging combined with contrast-enhanced MR imaging in the follow-up of immunogene-treated glioblastoma multiforme. [2022]To assess the value of the combined use of dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging (MRI) and conventional contrast-enhanced MRI for the follow-up of treatment of glioblastoma multiforme (GBM).
Hypervascular tumor volume estimated by comparison to a large-scale cerebral blood volume radiographic atlas predicts survival in recurrent glioblastoma treated with bevacizumab. [2019]Dynamic susceptibility contrast (DSC)-MRI is a well-established perfusion MR imaging technique for estimating relative cerebral blood volume (CBV) in primary brain tumors; however, tumors localized to regions with naturally elevated perfusion, including cortical tissue and common vascular territories, make evaluation of tumor vascularity difficult to assess. In the current study, we have constructed a large-scale radiographic atlas of CBV to assess treatment response to bevacizumab in individual patients with recurrent glioblastoma.
Dynamic-susceptibility contrast agent MRI measures of relative cerebral blood volume predict response to bevacizumab in recurrent high-grade glioma. [2022]The anti-VEGF antibody, bevacizumab, is standard treatment for patients with recurrent glioblastoma. In this setting, traditional anatomic MRI methods such as post-contrast T1-weighted and T2-weighted imaging are proving unreliable for monitoring response. Here we evaluate the prognostic significance of pre- and posttreatment relative cerebral blood volume (rCBV) derived from dynamic susceptibility contrast MRI to predict response to bevacizumab.
Misleading early blood volume changes obtained using ferumoxytol-based magnetic resonance imaging perfusion in high grade glial neoplasms treated with bevacizumab. [2018]Neovascularization, a distinguishing trait of high-grade glioma, is a target for anti-angiogenic treatment with bevacizumab (BEV). This study sought to use ferumoxytol-based dynamic susceptibility contrast magnetic resonance imaging (MRI) to clarify perfusion and relative blood volume (rCBV) changes in glioma treated with BEV and to determine potential impact on clinical management.
Relative cerebral blood volume is a potential predictive imaging biomarker of bevacizumab efficacy in recurrent glioblastoma. [2018]To analyze the relevance of dynamic susceptibility-weighted contrast-enhanced MRI (DSC-MRI) derived relative cerebral blood volume (rCBV) analysis for predicting response to bevacizumab (BEV) in patients with recurrent glioblastoma (rGB).
Potential 18F-RGD PET/CT and DCE-MRI Imaging-Based Biomarkers for Postoperative Survival Prediction Among Patients With Newly Diagnosed Glioblastoma Treated With Bevacizumab and Chemoradiotherapy. [2022]Label="Purpose" NlmCategory="UNASSIGNED">To investigate the ability of potential imaging biomarkers based on 18F-AlF-NOTA-PRGD2 positron emission tomography/computed tomography (18F-RGD PET/CT) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) imaging to predict the response to bevacizumab combined with conventional therapy in postoperative newly diagnosed glioblastoma.
Impact of imaging measurements on response assessment in glioblastoma clinical trials. [2021]We provide historical and scientific guidance on imaging response assessment for incorporation into clinical trials to stimulate effective and expedited drug development for recurrent glioblastoma by addressing 3 fundamental questions: (i) What is the current validation status of imaging response assessment, and when are we confident assessing response using today's technology? (ii) What imaging technology and/or response assessment paradigms can be validated and implemented soon, and how will these technologies provide benefit? (iii) Which imaging technologies need extensive testing, and how can they be prospectively validated? Assessment of T1 +/- contrast, T2/FLAIR, diffusion, and perfusion-imaging sequences are routine and provide important insight into underlying tumor activity. Nonetheless, utility of these data within and across patients, as well as across institutions, are limited by challenges in quantifying measurements accurately and lack of consistent and standardized image acquisition parameters. Currently, there exists a critical need to generate guidelines optimizing and standardizing MRI sequences for neuro-oncology patients. Additionally, more accurate differentiation of confounding factors (pseudoprogression or pseudoresponse) may be valuable. Although promising, diffusion MRI, perfusion MRI, MR spectroscopy, and amino acid PET require extensive standardization and validation. Finally, additional techniques to enhance response assessment, such as digital T1 subtraction maps, warrant further investigation.