Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
Primary Purpose
Meningioma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ga-68- DOTATATE
Ga-68-DOTATOC
Sponsored by
About this trial
This is an interventional diagnostic trial for Meningioma
Eligibility Criteria
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.
Sites / Locations
- Weill Cornell Medical College of Cornell UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Meningioma
Arm Description
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04298541
First Posted
March 4, 2020
Last Updated
April 18, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04298541
Brief Title
Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
Official Title
SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Visit 1 Patients will undergo a 68-Ga-DOTATATE PET/CT or PET/MR scan as standard of care, or as part of a separate research study.
Visit 2 At least 24h and up to 4 weeks apart from Visit 1, patients will undergo 68Ga-DOTATOC PET/CT scan.
Follow-up Phase Patients enrolled in the study are planned for surgery as part of SOC. After the two scans, patients will undergo surgery and a histopathologic analysis of the resected tumor will be performed. The histopathology results will be used to correlate molecular biomarkers with imaging parameters. During the follow up period a review of clinical and imaging records related to the diagnosis will be conducted by the research team as part of the study during the follow- up period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Meningioma
Arm Type
Experimental
Arm Description
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.
Intervention Type
Drug
Intervention Name(s)
Ga-68- DOTATATE
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ga-68-DOTATOC
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Over 12 months
Title
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.
Description
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.
Time Frame
Over 12 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Over 12 months
Title
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.
Description
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.
Time Frame
Over 12 months
Title
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.
Description
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.
Time Frame
Over 12 months
Title
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.
Description
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.
Time Frame
Over 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jana Ivanidze, MD/Ph.D
Phone
212-746-6000
Email
jai9018@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Chang
Phone
646-962-6282
Email
eic2002@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana Ivanidze, MD/Ph.D
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jana Ivanidze, MD/Ph.D
Phone
212-746-6000
Email
jai9018@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Eileen Chang
Phone
646-962-6282
Email
eic2002@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jana Ivanidze, MD/Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
We'll reach out to this number within 24 hrs