An interventional study of UR-ddPCR in Glioma, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
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.
Device: UR-ddPCR
The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.
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)
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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NYU Langone Health