Neoplasms

Nervous System Diseases

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Meningioma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

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

Brain Imaging with [Cu64]DOTATATE

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.

Radio-guided Surgery With Neoprobe Utilization

Jana Ivanidze, MD/PhD

Alexis Watson

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

Objectives:

Primary objectives: The primary objective of this pilot study is to evaluate the feasibility of intraoperative tumor detection using \[Cu64\]DOTATATE. The study team further wants to validate the gamma count measurements using pre- and post-operative Positron Emission Tomography (PET) standardized uptake value (SUV) .

Secondary Objectives: To correlate intraoperative tracing findings with from pathology markers ( World Health Organization grade (WHO grade), Ki-67, Somatostatin Receptor 2 expression (SSTR2A expression), Estrogen receptor expression (ER expression), Progesterone receptor expression (PR expression)) using samples obtained as part of routine surgical care. To evaluate the correlation of post resection gamma count with longitudinal PET follow up.

Exploratory objectives: To establish best practices for integration of intraoperative tumor tracing using the neoprobe into the surgical workflow. To determine surgical candidates who will benefit most from intraoperative tracing based on tumor location, MRI features, etc.

Overall Design:

This is a single-center prospective observational pilot study to determine the feasibility of using \[Cu64\]DOTATATE for intraoperative tumor detection. 20 patients diagnosed with meningioma by conventional magnetic resonance imaging (MRI) who are candidates for surgical resection will be enrolled. Enrollment will be facilitated by colleagues in the neurosurgery department (also co- investigators on this study) with whom the PI has had several years of collaboration and an ongoing referral stream (6pprox.. 5 patients per week).

Patients will subsequently undergo pre-operative \[Cu64\]DOTATATE PET/MRI 12-24 hours prior to surgery. Given that \[Cu64\]DOTATATE has a much longer half-life compared to \[Ga68\]DOTATATE, it is uniquely suited for this application, allowing the patient to be injected once with the clinically approved dose, undergo immediate Positron Emission tomography scan and magnetic resonance imaging scan (PET/MRI) or Positron Emission tomography scan and computed tomography scan (PET/CT), and undergo resection the following day with sufficient radiotracer in situ for radio-guided surgery (RGS).

During the operation, the neurosurgeon will make a number of measurements using the neoprobe (available at our institution and currently in frequent routine clinical use for intraoperative sentinel node detection; commonly used for breast cancer, melanoma, oral cancer):

1. After exposing the tumor, and immediately before removal, tumor counts will be documented with the neoprobe. This count will be correlated with preoperative \[Cu64\]DOTATATE SUV to evaluate the relationship between radiographic radiotracer uptake and intraoperative radioactivity of the tumor.
2. After removing all tumor that can be removed safely, the surgeon will grade whether they feel they obtained a gross total resection (GTR) or whether tumor was left behind (subtotal resection (STR), e.g. because the surgeon had to leave behind tumor attached to critical structure). In case of STR, the neoprobe will be used to measure counts in the remaining tumor. In case of presumed GTR, the neoprobe will be used to measure counts in the resection cavity. This second count will be correlated with post-operative \[Cu64\]DOTATATE SUV to evaluate the effectiveness of this method in evaluating residual tumor.

These steps will not alter the regular course of the surgery in any way. Patients will have two follow-up points after the surgery: 1) at 6 weeks to 3 months post-op and 2) at 6 months to 12 months post-op. Patients will be clinically examined and will undergo repeat \[Cu64\]DOTATATE PET/MRI or PET/CT during these follow up visits, as standard of care, with radiotracer dosage being funded by the study for the 1st follow up scan, and determined standard of care for the 2nd follow up scan.

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

preoperative lesion \[Cu64\]DOTATATE PET SUV

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

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

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

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.

follow-up MRI assessment of progression based on RANO guidelines

Neoprobe count of the target lesion prior to resection.

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

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)

immunohistochemistry analysis of SSTR2 expression in the resected tumor

determined histomorphologically based on pathologist's assessment of resected tumor tissue.

Ki67 Proliferation Index (percentage of positively stained tumor cells among the total number of malignant cells assessed).

determined based on pathologist's assessment of resected tumor tissue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE	NCT06377371	Meningioma	Brain Imaging w... Radio-guided Su...	18 Years - 99 Years	Weill Medical College of Cornell University
Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE	NCT06377371	Meningioma	Brain Imaging w... Radio-guided Su...	18 Years - 99 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for brain imaging with [cu64]dotatate