Residual IDH1-Mutant Tumor Cell Quantification Study for Glioma

This study is looking at a new way to detect remaining tumor cells during surgery for glioma, a type of brain tumor. It uses an investigational device called UR-ddPCR to quickly check for IDH1-mutant tumor cells right after a tumor is removed. If these cells are found, it can help guide surgeons to remove more tumor in real-time. You might be able to join if you are 18 or older, have a newly diagnosed glioma with features of an IDH-mutant tumor, and are scheduled for surgery at NYU Langone Health. The study aims to see how long patients live without their disease getting worse (Progression-Free Survival) for up to three years after the procedure. The current recruitment status is unclear.

Study design
This is a single-site study involving about 105 participants. It is an interventional study, meaning participants will receive a specific intervention.
What's involved
The investigational UR-ddPCR assay will be performed on tissue collected during your scheduled surgical visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for Progression-Free Survival for up to three years after the procedure.

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NCT07219199

Residual IDH1-Mutant Tumor Cell Quantification Study

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
NYU Langone Health
~105 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:UR-ddPCR

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to Year 3 Post-Procedure
Glioma
1 sites across 1 states
New York1
  • Daniel Orringer, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

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
  • Progression-Free Survival (PFS)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).