NCT06377371 Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
| NCT ID | NCT06377371 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-11 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2024-09-11 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.
Eligibility 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
Contact & Investigator
Jana Ivanidze, MD/PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06377371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06377371 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06377371 currently recruiting?
Yes, NCT06377371 is actively recruiting participants. Contact the research team at jai9018@med.cornell.edu for enrollment information.
Where is the NCT06377371 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06377371 clinical trial?
NCT06377371 is sponsored by Weill Medical College of Cornell University. The principal investigator is Jana Ivanidze, MD/PhD at Weill Medical College of Cornell University. The trial plans to enroll 20 participants.