Residual IDH1-Mutant Tumor Cell Quantification Study

NYU Langone Health

Status: Not yet enrolling

Conditions: Glioma

Treatments: Device: UR-ddPCR

Study type: Interventional

Funder types: Other

Identifiers

NCT07219199

Pending-IDE G250266

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

UR-ddPCR During Tumor Biopsy/Resection Procedure

Experimental group

Description:

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.

Treatment:

Device: UR-ddPCR