NCT05281731招募中不适用
Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of sonobiopsy as measured by change in ctDNA level
研究概览
简要总结
This clinical study to evaluate sonobiopsy is significant because sonobiopsy will fundamentally enhance the clinician's insight into the molecular features of an intracranial lesion to tailor treatment approaches and optimize outcomes. In addition to the standard diagnostics of anatomic imaging and surgical histology, sonobiopsy has the potential to become the third pillar for brain tumor management by radically advancing the ability to easily and regularly acquire tumor genetic and molecular signatures. This enhanced capability will have a dramatic impact on patient survival and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be newly diagnosed with a lesion in the brain with imaging characteristics consistent with glioblastoma multiforme. Scan must have occurred no more than 28 days prior to enrollment.
- •Lesion must be > 3 cm in maximal dimension on MRI.
- •Lesion must be in the supratentorial space within 5 cm of the cortical surface.
- •Lesion must be gadolinium enhancing.
- •Low grade tumors and metastatic tumors
- •Recurrent brain tumors and/or radiation necrosis
- •Must be planning to undergo surgical resection of the tumor.
- •Must be at least 18 years old.
- •Patients with recurrent GBM who are planning to undergo surgical resection or laser ablation of the recurrent tumor. Recurrence must be confirmed on MRI performed no more than 28 days prior to enrollment.
排除标准
- •Contraindication to MRI.
- •Previous cranial surgery.
- •Previous history of cancer and/or cancer treatments.
- •Coagulopathy within 14 days of enrollment defined as PT/PTT outside of normal parameters and platelets < 100,000/mcL.
- •Physical skull defect of any kind.
- •Ferrous material in the scalp or skull.
- •Scalp or skin disease that limits contact with the ultrasound probe.
- •Enrolled in another clinical trial where intervention is administered prior to surgery.
- •Known hypersensitivity to polyethylene glycol.
- •Known unstable cardiopulmonary condition (e.g. acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
研究组 & 干预措施
Sonobiopsy
Experimental
- Once enrolled, participants would be prepared for standard of care surgery.
- The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur.
- An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence.
- Blood will be collected at several time points.
- A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor.
- The blood, tumor, and skin (if applicable) will undergo genetic analysis.
干预措施: Sonobiopsy (Device)
Sonobiopsy
Experimental
- Once enrolled, participants would be prepared for standard of care surgery.
- The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur.
- An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence.
- Blood will be collected at several time points.
- A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor.
- The blood, tumor, and skin (if applicable) will undergo genetic analysis.
干预措施: Research blood (Procedure)
Sonobiopsy
Experimental
- Once enrolled, participants would be prepared for standard of care surgery.
- The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur.
- An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence.
- Blood will be collected at several time points.
- A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor.
- The blood, tumor, and skin (if applicable) will undergo genetic analysis.
干预措施: Cancer Personalized Profiling (Genetic)
Sonobiopsy
Experimental
- Once enrolled, participants would be prepared for standard of care surgery.
- The sonobiopsy involves the standard procedure for a biopsy, but the biopsy needle is replaced with a customized ultrasound probe, a standard ultrasound contrast agent (microbubbles) is injected intravenously, and the probe is turned on for 3 minutes for the sonobiopsy. Then the planned surgery to remove the tumor will occur.
- An additional brief MRI scan will be obtained using the intraoperative MRI to define imaging changes (if any) that occur as a result of the sonobiopsy procedure. The imaging protocols will include a 3D T2-weighted (T2w) scan, and 3D contrast T1-weighted (T1w) with dynamic contrast enhancement and if time allows T2* sequence.
- Blood will be collected at several time points.
- A small skin biopsy or another blood draw will be drawn for comparison against the genetic mutations shown in the tumor.
- The blood, tumor, and skin (if applicable) will undergo genetic analysis.
干预措施: Definity® (Device)
结局指标
主要结局
Feasibility of sonobiopsy as measured by change in ctDNA level
时间窗: Day 1
The feasibility of sonobiopsy will be demonstrated by an increase in the amount of ctDNA in the blood samples acquired post than prior sonobiopsy in at least 50% of the patients.
Number of matched mutations between the post-sonobiopsy sample and the tumor tissue sample
时间窗: Day 1
The agreement of the post-sonobiopsy sample mutation detected in the blood with a variant identified in the tumor tissue will be compared using a kappa statistic.
次要结局
未报告次要终点
研究者
研究点 (1)
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