Residual IDH1-Mutant Tumor Cell Quantification Study

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07219199
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UR-ddPCR — DEVICE
    The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
105 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to Year 3 Post-Procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By specialty
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By research site
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