Trials / Not Yet Recruiting
Not Yet RecruitingNCT07219199
Residual IDH1-Mutant Tumor Cell Quantification Study
Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UR-ddPCR | The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit. |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2030-12-01
- Completion
- 2030-12-01
- First posted
- 2025-10-21
- Last updated
- 2025-10-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07219199. Inclusion in this directory is not an endorsement.