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NCT Number: NCT07219199

Residual IDH1-Mutant Tumor Cell Quantification Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

UR-ddPCR

Device

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to Year 3 Post-Procedure

    OS is defined as the time from surgery to the time of death due to any cause (whichever occurs earlier).

  2. Residual Tumor Volume

    Time frame: Postoperative Day 1 (POD1)

    Assessed via MRI.

  3. Radiographic PFS

    Time frame: Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure

    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).

  4. Time to Radiographic Recurrence

    Time frame: Up to Year 3 Post-Procedure

    Time to Radiographic Recurrence is defined as the time from surgery to the time of the first MRI demonstrating radiographic recurrence.

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Orringer, MD

CONTACT

[email protected]

(212) 263-0909

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Oct 21, 2025
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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