Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

NCT06377371 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-03025815
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Preoperative [Cu64]DOTATATE PET SUV

  preoperative lesion \[Cu64\]DOTATATE PET SUV

  At time of enrollment

• 1st Post-operative [Cu64]DOTATATE PET SUV

  6 weeks to 3 months follow up post operative \[Cu64\]DOTATATE PET SUV

  3 months

• 2nd Post-operative [Cu64]DOTATATE PET SUV

  6 months to 12 months follow up post operative \[Cu64\]DOTATATE PET SUV

  1 year

• MRI Size Measurements

  preoperative size measurements based on Response Assessment in Neuro-Oncology (RANO) guidelines

  At time of enrollment

• GTR vs STR Assessment

  postoperative MRI-based assessment of GTR versus STR by a neuroradiologist, as determined by the presence or absence of nodular dural-based enhancement on post contrast 3D T1-weighted MR imaging and direct comparison to preoperative MRI.

  6 weeks- 3 months

• MRI Progression Assessment

  follow-up MRI assessment of progression based on RANO guidelines

  6-12 months

• Target Lesion Neoprobe Count

  Neoprobe count of the target lesion prior to resection.

  At time of enrollment

• Subtotal Neoprobe Count

  Neoprobe count of the subtotally resected tumor or the resection cavity in case of presumed GTR post resection.

  At time of enrollment

• Reference Background Neoprobe Count

  Neoprobe count of the reference background measured at least 1 cm away from the tumor (measured in at least two locations depending on the operative field)

  At time of enrollment

Secondary Outcomes (4)

• SSTR2 expression

  At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).

• WHO grade

  At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).

• Ki67 Proliferation Index

  At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).

• ER/PR expression

  At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).

Study Arms (1)

Patients with MRI findings compatible with meningioma who have an indication for surgery

EXPERIMENTAL

A diagnostic intervention in which patients will undergo intraoperative meningioma tracing using \[Cu64\]DOTATATE.

Diagnostic Test: Brain Imaging with [Cu64]DOTATATE; Procedure: Radio-guided Surgery With Neoprobe Utilization

Interventions

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.

Patients with MRI findings compatible with meningioma who have an indication for surgery

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.

Patients with MRI findings compatible with meningioma who have an indication for surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Curium US LLC: collaborator

Study Sites (1)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Jana Ivanidze, MD/PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Ivanidze, MD/PhD

CONTACT

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

Alexis Watson

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 22, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)