Residual IDH1-Mutant Tumor Cell Quantification Study

NCT07219199 | Not Yet Recruiting FDA Device

• 1 other identifier: Pending-IDE G250266
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to Year 3 Post-Procedure

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to Year 3 Post-Procedure

• Residual Tumor Volume

  Postoperative Day 1 (POD1)

• 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)

Study Arms (1)

UR-ddPCR During Tumor Biopsy/Resection Procedure

EXPERIMENTAL

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

Interventions

UR-ddPCR DEVICE

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

UR-ddPCR During Tumor Biopsy/Resection Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Daniel Orringer, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Orringer, MD

CONTACT

(212) 263-0909; Daniel.Orringer@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 21, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)