Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a single-site, single-arm, prospective, interventional cohort study using intraoperative ultra-rapid droplet digital polymerase chain reaction (UR- ddPCR) to assess residual IDH1-mutant tumor at the end of surgical resection and, if positive, guide additional resection in real-time.
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
- •Age ≥ 18 years at the time of consent (any sex)
- •Newly diagnosed diffuse glioma with either (a) radiographic features consistent with IDH-mutant glioma or (b) prior molecular confirmation of an IDH mutation
- •Scheduled for tumor tissue biopsy or surgical resection at NYU Langone Health
排除标准
- •Active hepatitis C virus (HCV) infection or suspected/confirmed prion disease (e.g., Creutzfeldt-Jakob disease), as documented in the medical record or by the treating physician, due to biosafety and tissue- handling restrictions
研究组 & 干预措施
UR-ddPCR During Tumor Biopsy/Resection Procedure
During the participant's tumor biopsy or resection, the neurosurgeon will perform maximal safe resection, as per standard clinical practice, and allocate nine tissue specimens (three from the core of the tumor and six from the tumor-brain interface) for UR-ddPCR testing. If both core and tumor-brain interface samples test positive and further removal is judged safe, the neurosurgeon may perform additional resection and obtain final specimens from the positive sites before concluding the surgery. Up to 15 tissue specimens may be collected and tested during the procedure. Postoperative care and clinical follow-up will proceed per standard of care.
干预措施: UR-ddPCR (Device)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to Year 3 Post-Procedure
PFS is defined as the time from surgery to the time of the first MRI demonstrating radiographic progression (using Response Assessment in Neuro-Oncology \[RANO\] criteria) or death due to any cause (whichever occurs earlier).
次要结局
- Residual Tumor Volume(Postoperative Day 1 (POD1))
- Overall Survival (OS)(Up to Year 3 Post-Procedure)
- Radiographic PFS(Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure)
- Time to Radiographic Recurrence(Up to Year 3 Post-Procedure)
- Percent Change in Mutant Allele Fraction (MAF)(Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3))