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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
105
The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.
NYU Langone Health
New York, New York, United States
Progression-Free Survival (PFS)
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).
Time frame: Up to Year 3 Post-Procedure
Overall Survival (OS)
OS is defined as the time from surgery to the time of death due to any cause (whichever occurs earlier).
Time frame: Up to Year 3 Post-Procedure
Residual Tumor Volume
Assessed via MRI.
Time frame: Postoperative Day 1 (POD1)
Radiographic PFS
Radiographic 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).
Time frame: Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure
Time to Radiographic Recurrence
Time to Radiographic Recurrence is defined as the time from surgery to the time of the first MRI demonstrating radiographic recurrence.
Time frame: Up to Year 3 Post-Procedure
Percent Change in Mutant Allele Fraction (MAF)
Time frame: Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.