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Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

NCT06377371 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this study

Summary

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

Conditions

  • Meningioma

Interventions

DIAGNOSTIC_TEST

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Curium US LLC

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jana Ivanidze, MD/PhD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06377371 on ClinicalTrials.gov