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A Novel Approach to Determining Tumor Progression Using a Three-Site Pilot Clinical Trial of Spectroscopic MRI-Guided Radiation Dose Escalation in Glioblastoma.

ABSTRACT: Glioblastoma (GBM) is a fatal disease, with poor prognosis exacerbated by difficulty in assessing tumor extent with imaging. Spectroscopic MRI (sMRI) is a non-contrast imaging technique measuring endogenous metabolite levels of the brain that can serve as biomarkers for tumor extension. We completed a three-site study to assess survival benefits of GBM patients when treated with escalated radiation dose guided by metabolic abnormalities in sMRI. Escalated radiation led to complex post-treatment imaging, requiring unique approaches to discern tumor progression from radiation-related treatment effect through our quantitative imaging platform. The purpose of this study is to determine true tumor recurrence timepoints for patients in our dose-escalation multisite study using novel methodology and to report on median progression-free survival (PFS). Follow-up imaging for all 30 trial patients were collected, lesion volumes segmented and graphed, and imaging uploaded to our platform for visual interpretation. Eighteen months post-enrollment, the median PFS was 16.6 months with a median time to follow-up of 20.3 months. With this new treatment paradigm, incidence rate of tumor recurrence one year from treatment is 30% compared to 60-70% failure under standard care. Based on the delayed tumor progression and improved survival, a randomized phase II trial is under development (EAF211).

SUBMITTER: Ramesh KK

PROVIDER: S-EPMC9964256 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

A Novel Approach to Determining Tumor Progression Using a Three-Site Pilot Clinical Trial of Spectroscopic MRI-Guided Radiation Dose Escalation in Glioblastoma.

Ramesh Karthik K KK Huang Vicki V Rosenthal Jeffrey J Mellon Eric A EA Goryawala Mohammed M Barker Peter B PB Gurbani Saumya S SS Trivedi Anuradha G AG Giuffrida Alexander S AS Schreibmann Eduard E Han Hui H de le Fuente Macarena M Dunbar Erin M EM Holdhoff Matthias M Kleinberg Lawrence R LR Shu Hui-Kuo G HG Shim Hyunsuk H Weinberg Brent D BD

Tomography (Ann Arbor, Mich.) 20230206 1

Glioblastoma (GBM) is a fatal disease, with poor prognosis exacerbated by difficulty in assessing tumor extent with imaging. Spectroscopic MRI (sMRI) is a non-contrast imaging technique measuring endogenous metabolite levels of the brain that can serve as biomarkers for tumor extension. We completed a three-site study to assess survival benefits of GBM patients when treated with escalated radiation dose guided by metabolic abnormalities in sMRI. Escalated radiation led to complex post-treatment ...[more]

PMID: 36828381

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Project description:Abstract The standard of care for glioblastoma is neurosurgical resection followed by radiation therapy (RT) and temozolomide (TMZ) chemotherapy. Although RT is effective for glioblastoma, attempts to improve survival using RT dose escalation above 60 Gy have been largely unsuccessful. This may be because prior attempts have been targeted to resection cavity or enhancing tumor, which may not accurately predict areas at highest recurrence risk. To overcome the limitations of standard T1 and T2-weighted MRI in predicting tumor recurrence, we have shown that supplementation with 3D high-resolution spectroscopic MRI (sMRI) identifies actively proliferating tumor beyond areas of T1-enhancement by measuring endogenous metabolites and their ratios. Previously, we demonstrated that the choline to N-acetylaspartate ratio (Cho/NAA) best correlates with tumor cellularity in surgically resected tissue (ρ=0.82, p< 0.001) and, most importantly, areas of sMRI metabolic abnormalities predate disease recurrence in those same areas (Cordova et al, Neuro-Oncology 2016). Therefore, we seek to identify whether sMRI can be used by radiation oncologists to choose the optimal regions to target for RT dose escalation. To assess its feasibility and safety, we developed a web-based imaging platform designed specifically to incorporate sMRI into the RT planning clinical workflow and are using it in a multisite sMRI-guided dose escalation trial (NCT03137888; Emory, Johns Hopkins, U. Miami). Recently, we have completed full enrollment including 30 patients treated with sMRI-guided dose escalated RT across three institutions. We have demonstrated successful integration of sMRI into the RT planning workflow, and we have delivered sMRI-guided dose escalated RT plans to glioblastoma patients without severe adverse events to date. Follow-up data will be analyzed for overall and progression-free survival. Based on the feasibility and safety of this technique in the current trial, we plan to assess the efficacy of sMRI-guided dose-escalated RT on patient outcomes in a NCTN clinical trial.

Dataset Information

A Novel Approach to Determining Tumor Progression Using a Three-Site Pilot Clinical Trial of Spectroscopic MRI-Guided Radiation Dose Escalation in Glioblastoma.

Publications

A Novel Approach to Determining Tumor Progression Using a Three-Site Pilot Clinical Trial of Spectroscopic MRI-Guided Radiation Dose Escalation in Glioblastoma.

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