UR-ddPCR for Brain Cancer

DO
Overseen ByDaniel Orringer, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

DO

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

My brain tumor is newly diagnosed and either looks like or has been confirmed to have an IDH mutation.
I am 18 years old or older.
I am scheduled for a biopsy or surgery at NYU Langone Health.

Exclusion Criteria

I do not have active hepatitis C or any prion diseases like Creutzfeldt-Jakob.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Intraoperative UR-ddPCR is used to assess residual IDH1-mutant tumor and guide additional resection if necessary

1 day
1 visit (in-person)

Postoperative Care

Postoperative care and clinical follow-up proceed per standard of care

1 week

Follow-up

Participants are monitored for safety and effectiveness after surgery, including MRI assessments for progression and recurrence

Up to 3 years
Regular visits for MRI assessments at Month 6, 12, 24, and 36

What Are the Treatments Tested in This Trial?

Interventions

  • UR-ddPCR
Trial Overview The study tests the use of ultra-rapid droplet digital polymerase chain reaction (UR-ddPCR) during brain tumor surgery. It aims to detect any remaining IDH1-mutant tumor cells after initial removal and guide further resection in real-time if needed.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: UR-ddPCR During Tumor Biopsy/Resection ProcedureExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40010345/
Ultra-rapid droplet digital PCR enables intraoperative ...We introduce Ultra-Rapid droplet digital PCR (UR-ddPCR), a technology that achieves the fastest measurement, to date, of mutation burdens in tissue samples.
Ultra-Rapid Droplet Digital PCR Expedites and Refines ...Ultra-rapid droplet digital PCR detects brain cancer mutations and cell load within 15 minutes during surgery.
New 'Ultra-Rapid' ddPCR Test Could Revolutionize Brain ...In tests on 75 tissue samples from 22 patients undergoing glioma tumor surgery, UR-ddPCR showed consistent results with both standard ddPCR and ...
Ultra-Rapid Molecular-Genetic Assays Feasible for Tumor ...The clinical feasibility of UR-ddPCR was assessed by intraoperative use in 22 brain tumor cases, with multiple tissue samples per case (78 ...
'Ultra-Rapid' Testing Unlocks Cancer Genetics in the ...The researchers showed that UR-ddPCR had markedly faster processing speed than standard droplet digital polymerase chain reaction (ddPCR).
"Ultra-Rapid" Testing Unlocks Cancer Genetics in the ...For the study, researchers used UR-ddPCR to measure the levels of two genetic mutations, IDH1 R132H and BRAF V600E, which are prevalent in brain ...
UR-ddPCR for Brain Cancer · Info for ParticipantsThis N/A medical study run by NYU Langone Health needs participants to evaluate whether UR-ddPCR will have tolerable side effects & efficacy for patients ...
Portable Duplex Digital PCR for On-Site Detection of IDH ...Accurate identification of critical genetic markers in brain tumors, such as isocitrate dehydrogenase (IDH) mutations, is vital for ...
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