Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure
研究概览
简要总结
Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.
详细描述
Glioblastomas (GBs) are aggressive malignant brain tumors with a median survival of less than 15 months . Infiltration of cancer beyond the tumor margins causes recurrence in nearly 100% of GBs; however, this cannot be measured by current imaging techniques . Availability of reliable and reproducible infiltration prediction maps at initial diagnosis will open new treatment opportunities such as targeted surgery or escalated radiation therapy (RT).
On clinical contrast enhanced (CE) magnetic resonance imaging (MRI) scans, a typical GB demonstrates an enhancing mass with central necrosis and an extensive surrounding, peritumoral region with bright signal on T2-weighted(w) and FLAIR (Fluid attenuation inversion recovery) images. This bright, peritumoral T2/FLAIR region is known to contain vasogenic edema and tumor infiltration, as it is well known that GBs infiltrate beyond the enhancing tumor margins.
Since there is a clear link between extent of tumor resection and survival the challenge for neurosurgeons is maximizing resection of tumor, while avoiding neurological injury. Typically, the central region of the tumor can be safely resected with minimal risk. The challenge lies in maximal safe resection along the tumor margins as it infiltrates normal brain. MR Fingerprinting is a quantitative imaging (QI) scan developed at CWRU that provides rapid quantification of multiple tissue properties, such as T1 and T2 relaxation maps, with high reproducibility and excellent tissue characterization. Our preliminary analysis of retrospective data of 60 GB participants with MRF+MRI scans with targeted 5-aminolevulenic acid (5-ALA) tissue sampling demonstrates an AUC of 0.8 for MRF/MRI model for GBM infiltration prediction in peritumoral region .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The neurosurgeons and participants will not be masked to the treatment group assignment, but the team members looking at outcome assessment will be blinded.
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Age > 18
- •MR imaging findings suggestive of GB
- •Maximal tumor diameter greater than 3 cm
- •Ability to provide written informed consent
- •Ability to undergo MRI scan
- •Consideration for biopsy, subtotal or gross total resection.
排除标准
- •Contraindications to MRI
- •Contraindication to surgical treatment
- •Prior treatment for glioblastoma
- •Inclusion Criteria:
- •Age > 18
- •MR imaging findings suggestive of GB
- •Maximal tumor diameter greater than 3 cm
- •Ability to provide written informed consent
- •Ability to undergo MRI scan
- •Lesions amenable to gross total resection
- •Presence of peritumoral FLAIR signal abnormality beyond the area of enhancement.
- •Exclusion Criteria:
- •Inability to undergo MRI imaging
- •Participants undergoing only stereotactic biopsy or less than gross total resection
- •Participants undergoing LITT
- •Inability to consent for the study
- •Previously treated/ recurrent glioma.
研究组 & 干预措施
Group 2
The surgeon will have access to advanced MRI and MRF analysis research images during surgery and may use them for guidance, in addition to all routinely used surgical tools.
干预措施: MRF/MRI infiltration guidance for extended resection (Procedure)
Group 1
Routine standard of care process will be followed for neurosurgical guidance
干预措施: Control Group - Standard of care neurosurgical resection (Other)
结局指标
主要结局
Number of participants who experienced serious adverse events(SAEs) at 30 days post targeted biopsy sampling procedure
时间窗: 30 days post surgery
Safety is defined as the absence of significant complications at 30 days. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Number of participants who experienced serious adverse events(SAEs) at 48 hours post targeted biopsy sampling procedure
时间窗: 48 hours post surgery
Safety is defined as the absence of significant complications at 48 hours. SAEs are measured using BTM(Bayesian toxicity monitorin) algorithm
Feasibility as assessed by the performance of MRF/MRI infiltration mapping guidance in surgical resection of new glioblastomas
时间窗: Up to 72 hours post surgery
Assessed by post surgical MRI scans
次要结局
- Recurrence(Approximately 12 months post surgery)
- Histopathological correlation(Approximately one week post surgery)
- Progression Free Survival(PFS)(6 months)
- Extent of resection(1 week post surgery)
- Operator confidence(1 week post surgery)
