Residual IDH1-Mutant Tumor Cell Quantification Study
ConditionGlioma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
UR-ddPCR
DeviceThe investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.
Treatment groups
105 Participants
are divided into 1 treatment groupGroup A: UR-ddPCR During Tumor Biopsy/Resection ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
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).
Time frame
Up to Year 3 Post-ProcedureSecondary outcomes
1
Overall Survival (OS)
OS is defined as the time from surgery to the time of death due to any cause (whichever occurs earlier).
Time frame
Up to Year 3 Post-Procedure2
Residual Tumor Volume
Assessed via MRI.
Time frame
Postoperative Day 1 (POD1)3
Radiographic PFS
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 frame
Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure4
Time to Radiographic Recurrence
Time to Radiographic Recurrence is defined as the time from surgery to the time of the first MRI demonstrating radiographic recurrence.
Time frame
Up to Year 3 Post-ProcedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: