RecruitingPhase 4NCT06377371

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE


Sponsor

Weill Medical College of Cornell University

Enrollment

20 participants

Start Date

Sep 11, 2024

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

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

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.


Locations(1)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

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NCT06377371


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