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A Pilot Study to Evaluate Feasibility of Intraoperative Gamma Probe Tracing of Meningioma using [Cu64] DOTATATE

Clinical Trial Details

The purpose of this research is to evaluate the feasibility of using the radiotracer [Cu64]DOTATATE to detect tumors intraoperatively (during surgery) for patients with meningioma.

[Cu64]DOTATATE is a U.S. Food and Drug Administration (FDA) approved PET (positron emission tomography) radiotracer for the imaging of tumors that have a specific marker on their surface (somatostatin receptor). It has not yet been evaluated on whether it can help assess the extent of tumor removed during surgery.

Meningiomas have high levels of somatostatin receptors on their surface while cells making up the normal brain and normal brain coverings (dura) do not. Therefore, we can use PET radiotracers targeting somatostatin receptors to better visualize meningiomas. 

Participants will undergo a PET/CT or PET/MR scan of the head with [Cu64]DOTATATE 12-24 hours prior to standard of care surgery. During surgery, the neurosurgeon will use a handheld device called a gamma probe to measure the levels of this radiotracer immediately before and after removal of the tumor. 

Following surgery, participants will undergo a second [Cu64]DOTATATE PET/CT or PET/MR scan between 6 weeks and 3 months, and then a third scan between 6 months to 12 months. 

Key Eligibility: 
  1. Open to patients over 18 years of age 
  2. Open to patients with 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.
  3. Patients may not be pregnant or breastfeeding. 
  4. Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed.
  5. Patients with hypersensitivity to somatostatin analogs, contraindications to conventional MRI, and/or prior history of cranial radiation therapy may not be enrolled. 
  6. Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded.

Detailed eligibility will be discussed when reaching out to the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

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

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2303025815

ClinicalTrials.gov:

NCT06377371

Status

Not Yet Recruiting

Age Group

Adult

Sponsor

Disease