Recruiting

CU64 DOTATATE

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06377371

Conditions

Meningioma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brain Imaging with [Cu64]DOTATATE

Radio-guided Surgery With Neoprobe Utilization

Study Details

Brief summary:

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

Conditions

Meningioma

Study ID

NCT06377371

Start date

Sep 11, 2024

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Brain 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.

Radio-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.

Primary outcome measure

  • Preoperative [Cu64]DOTATATE PET SUV [ Time Frame: At time of enrollment ]
  • 1st Post-operative [Cu64]DOTATATE PET SUV [ Time Frame: 3 months ]
  • 2nd Post-operative [Cu64]DOTATATE PET SUV [ Time Frame: 1 year ]
  • MRI Size Measurements [ Time Frame: At time of enrollment ]
  • GTR vs STR Assessment [ Time Frame: 6 weeks- 3 months ]
  • MRI Progression Assessment [ Time Frame: 6-12 months ]
  • Target Lesion Neoprobe Count [ Time Frame: At time of enrollment ]
  • Subtotal Neoprobe Count [ Time Frame: At time of enrollment ]
  • Reference Background Neoprobe Count [ Time Frame: At time of enrollment ]

Central Contacts and Locations

Central contacts

Jana Ivanidze, MD/PhD

212-746-4587jai9018@med.cornell.edu

Alexis Watson

646-962-2347alw4020@med.cornell.edu

Locations

New York-Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Jana Ivanidze, MD/PhD

212-746-4587jai9018@med.cornell.edu

Principal Investigator:

Jana Ivanidze, MD/PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-02-27.