Glioma
Conditions
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.
Interventions
DEVICEUR-ddPCR
The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Residual Tumor Volume | Postoperative Day 1 (POD1) | Assessed via MRI. |
| 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) | — |
Countries
United States
Contacts
Primary ContactDaniel Orringer, MD
Outcome results
None listed