A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
Weill Medical College of Cornell University
Summary
The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.
Description
Objectives: Primary objectives: The primary objective of this pilot study is to evaluate the feasibility of intraoperative tumor detection using \[Cu64\]DOTATATE. The study team further wants to validate the gamma count measurements using pre- and post-operative Positron Emission Tomography (PET) standardized uptake value (SUV) . Secondary Objectives: To correlate intraoperative tracing findings with from pathology markers ( World Health Organization grade (WHO grade), Ki-67, Somatostatin Receptor 2 expression (SSTR2A expression), Estrogen receptor expression (ER expression), Progesterone re…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 MR…
Interventions
- Diagnostic TestBrain Imaging with [Cu64]DOTATATE
Patients will undergo a \[Cu64\]DOTATATE PET/MRI or PET/CT before undergoing radio- guided surgery. Patients will undergo another \[Cu64\]DOTATATE PET/MRI or PET/CT 6 weeks- 3 months after their surgery, and 6 months- 12 months after surgery.
- ProcedureRadio-guided Surgery With Neoprobe Utilization
After the subjects undergo the preoperative \[Cu64\]DOTATATE PET/MRI, subjects will undergo radio-guided surgery in which the surgeon will utilize a standard intraoperative gamma probe (Neoprobe Gamma Detection System ®) to assess primary/residual tumor detection.
Location
- New York-Presbyterian/Weill Cornell Medical CenterNew York, New York