UR-ddPCR for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to detect leftover brain tumor cells during surgery. The treatment, called UR-ddPCR (a diagnostic technique), helps doctors determine if any tumor remains, allowing for safe removal of additional tissue if needed. It targets individuals with a specific type of brain cancer, IDH1-mutant glioma, undergoing surgery at NYU Langone Health. Those newly diagnosed with this tumor type and scheduled for surgery may be suitable candidates for the trial. As an unphased study, this trial offers participants the chance to contribute to pioneering research that could enhance surgical outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that UR-ddPCR is safe for brain cancer surgery?
Research has shown that UR-ddPCR is a new tool used during brain surgery to detect certain cancer cells. It works quickly and can identify even tiny amounts of these cells. However, limited information exists about its side effects or safety for patients. Since this study is not in a typical clinical trial phase, data on patient tolerance may be scarce. Researchers are still assessing its safety for people. Prospective participants should discuss any concerns with the study team or their doctor.12345
Why are researchers excited about this trial?
Researchers are excited about UR-ddPCR for brain cancer because it offers a new approach to evaluating tumor tissues during surgery. Unlike traditional methods that may rely on less precise techniques, UR-ddPCR enables real-time, highly sensitive detection of cancer cells at the tumor-brain interface and core. This allows surgeons to make informed decisions about further resection on the spot, potentially improving surgical outcomes and reducing the need for additional procedures. By providing immediate and accurate results, UR-ddPCR could significantly enhance postoperative care and patient recovery.
What evidence suggests that UR-ddPCR is effective for assessing residual brain cancer?
Research has shown that a new method called Ultra-Rapid droplet digital PCR (UR-ddPCR), which participants in this trial will undergo, can quickly detect brain cancer mutations during surgery. Tests on 75 tissue samples from 22 patients demonstrated that UR-ddPCR provided results matching standard methods but much faster. This speed allows doctors to check for cancer cells during the operation in just 15 minutes. The quick results help surgeons decide if they need to remove more of the tumor. This technology aims to improve surgery outcomes by ensuring no cancer is left behind.12678
Who Is on the Research Team?
Daniel Orringer, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a new diagnosis of diffuse glioma, which either looks like it has an IDH mutation on scans or has been confirmed to have one. Participants must be scheduled for a biopsy or surgery at NYU Langone Health and cannot join if they have active hepatitis C or suspected prion diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Intraoperative UR-ddPCR is used to assess residual IDH1-mutant tumor and guide additional resection if necessary
Postoperative Care
Postoperative care and clinical follow-up proceed per standard of care
Follow-up
Participants are monitored for safety and effectiveness after surgery, including MRI assessments for progression and recurrence
What Are the Treatments Tested in This Trial?
Interventions
- UR-ddPCR
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor