Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06377371
Phase
PHASE4
Status
Recruiting
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Conditions

  • Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Brain Imaging with [Cu64]DOTATATE — DIAGNOSTIC_TEST
    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.
  • Radio-guided Surgery With Neoprobe Utilization — PROCEDURE
    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.

Study Details

The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.

Key Dates

Start date
Sep 11, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with MRI findings compatible with meningioma who have an indication for surgery
    A diagnostic intervention in which patients will undergo intraoperative meningioma tracing using \[Cu64\]DOTATATE.

Primary Outcome Measure

Preoperative [Cu64]DOTATATE PET SUV [ Time Frame: At time of enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10021
Jana Ivanidze, MD/PhD
[email protected]
212-746-4587
Jana Ivanidze, MD/PhD (PRINCIPAL_INVESTIGATOR)

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By research site
New York-Presbyterian/Weill Cornell Medical Center· New York, NY

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