Residual IDH1-Mutant Tumor Cell Quantification Study

Not Applicable

Not yet recruiting

• Conditions: Glioma

• Registration Number: NCT07219199
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Study Start: 2025-12-01
• Primary Completion: 2030-12
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Residual Tumor Volume	Postoperative Day 1 (POD1)	Assessed via MRI.
Overall Survival (OS)	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).
Radiographic PFS	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).
Time to Radiographic Recurrence	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.
Percent Change in Mutant Allele Fraction (MAF)	Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3)

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States