Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC

SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC

The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

Study Overview

• Status: Not yet recruiting
• Conditions: Meningioma
• Intervention / Treatment: Drug: Ga-68- DOTATATE; Drug: Ga-68-DOTATOC

Detailed Description

The investigator is proposing a direct comparison of Ga-68-DOTATATE and -DOTATOC in a pilot cohort of patients with meningioma, and hypothesize non-inferiority of DOTATOC. This pilot study will form the basis for a subsequent prospective clinical trial and will allow us to optimize our existing imaging protocols, while developing a more cost-effective protocol.

Primary Objectives:

• Optimize the Ga-68-DOTATOC PET/CT protocol.
• Compare Ga-68-DOTATATE PET and -DOTATOC PET/CT in patients with meningioma.

Secondary Objectives

• Correlate Ga-68-DOTATATE PET and -DOTATOC PET/CT with clinical and pathological characteristics

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jana Ivanidze, MD/Ph.D; Phone Number: 212-746-6000; Email: jai9018@med.cornell.edu
• Study Contact Backup: Name: Eileen Chang; Phone Number: 646-962-6282; Email: eic2002@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical College of Cornell University
      • Contact: Jana Ivanidze, MD/Ph.D; Phone Number: 212-746-6000; Email: jai9018@med.cornell.edu
      • Principal Investigator: Jana Ivanidze, MD/Ph.D
      • Contact: Eileen Chang; Phone Number: 646-962-6282; Email: eic2002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with clinically suspected meningioma
• Patients planned for surgery - undergoing preoperative workup
• No contraindications to either radiotracer

Exclusion Criteria:

• Age less than 18 years
• Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Meningioma; Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

Drug: Ga-68- DOTATATE; The study intervention consists of two PET scans that will be performed using two different radiotracers, 68-Ga-DOTATATE and 68-Ga-DOTATOC. Ga-68-DOTATATE and 68-Ga-DOTATOC are PET radiotracers targeting somatostatin receptors. The study intervention consists of 2 PET scans that will be performed at least 24h apart using 68-Ga-DOTATATE and 68-Ga-DOTATOC radiotracers, in patients with suspected meningioma that are planned for subsequent surgery.; Drug: Ga-68-DOTATOC; The study intervention consists of two PET scans that will be performed using two different radiotracers, 68-Ga-DOTATATE and 68-Ga-DOTATOC. Ga-68-DOTATATE and 68-Ga-DOTATOC are PET radiotracers targeting somatostatin receptors. The study intervention consists of 2 PET scans that will be performed at least 24h apart using 68-Ga-DOTATATE and 68-Ga-DOTATOC radiotracers, in patients with suspected meningioma that are planned for subsequent surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.	Compare visual appearance qualitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Based on our pilot clinical case series, the following reference regions will be evaluated: Suspected meningioma;; Pituitary gland;; Superior sagittal sinus;; Brain parenchyma. Dynamic PET will be acquired and data will be analyzed including comparison of tissue-activity curves and Patlak analysis, as established by the PI in a pilot cohort. Extent of meningioma based on Ga-68-DOTATATE- and DOTATOC PET/CT will be compared to extent of disease as determined by MRI.	Over 12 months
Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.	Compare visual appearance quantitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Qualitative analysis will include evaluation by board certified radiologists with expertise in nuclear medicine/ molecular imaging who will be blinded to the radiotracer injected. Quantitative analysis will include extraction of the ratio of lesion's SUVmax values/reference regions.	Over 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.	Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically Ki67. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.	Over 12 months
Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.	Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically (epidermal growth factor receptor, EGFR). These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.	Over 12 months
Compare molecular biomarker (progesterone receptor) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (progesterone receptor) results to the maximum SUV ratio of target lesion to cranial blood pool.	Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically progesterone receptor. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.	Over 12 months
Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.	Patients enrolled in the study will subsequently undergo surgical resection of the lesion. The surgical specimen will be used for biomarker analysis to assess genetic information. The additional staining that will take place for research purposes includes, specifically SSTR2 expression. These parameters will be correlated with parameters acquired from the 68-Ga-DOTATATE and - DOTATOC PET scans.	Over 12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Cornell University
• Investigators: Principal Investigator: Jana Ivanidze, MD/Ph.D, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Edotreotide
• Other Study ID Numbers: 19-10021002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No