Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
Weill Medical College of Cornell University
20 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
Summary
The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.
Eligibility
Inclusion Criteria1
- 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 Criteria6
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06377371