Using a special imaging agent to detect meningioma during surgery
A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
This study is testing a special imaging agent to see if it can help doctors find meningioma tumors during surgery for patients who are having them removed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06377371 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of using [Cu64]DOTATATE for intraoperative detection of meningioma tumors. The study will involve 20 patients diagnosed with meningioma who are candidates for surgical resection, utilizing a gamma probe device to trace tumors after injection of the imaging agent. The study will also correlate intraoperative findings with pathology markers and assess the integration of this technique into surgical workflows. Additionally, it seeks to identify which surgical candidates may benefit most from this approach based on tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a high suspicion of meningioma requiring surgical resection based on MRI findings.
Not a fit: Patients who may not benefit include those undergoing specific surgical procedures where the neoprobe cannot be used or those with contraindications to MRI.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of tumor detection during surgery, potentially leading to better surgical outcomes for patients with meningioma.
How similar studies have performed: While this approach is innovative, similar studies using intraoperative imaging techniques have shown promise in other tumor types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria, or diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery. Exclusion Criteria: * Pregnant or breastfeeding * Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed * Patients with hypersensitivity to somatostatin analogs * Patients with contraindications to conventional MRI * Patients with prior history of cranial radiation therapy * Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded
Where this trial is running
New York, New York
- New York-Presbyterian/Weill Cornell Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jana Ivanidze, MD/PhD — Weill Medical College of Cornell University
- Study coordinator: Jana Ivanidze, MD/PhD
- Email: jai9018@med.cornell.edu
- Phone: 212-746-4587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.