Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04298541
Recruitment Status : Not yet recruiting
First Posted : March 6, 2020
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Cornell University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET and Ga-68-DOTATOC PET in patients with meningioma.

Condition or disease Intervention/treatment Phase
Meningioma Drug: Ga-68- DOTATATE Drug: Ga-68-DOTATOC Phase 2

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-DOTATATE and -DOTATOC PET protocol.
  • Compare Ga-68-DOTATATE and -DOTATOC PET in patients with meningioma.

Secondary Objectives

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

The study intervention consists of 2 PET/CT 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 68-Ga-DOTATATE PET/CT scan.

Visit 2 At least 24h 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. Patients are not required to return physically to the clinic for a follow-up visit. However, 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)
Primary Purpose: Diagnostic
Official Title: SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022


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/CT 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/CT 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/CT 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/CT 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 Measures :
  1. 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. [ Time Frame: Over 12 months ]

    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:

    1. Suspected meningioma;
    2. Pituitary gland;
    3. Superior sagittal sinus;
    4. 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.


  2. 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. [ Time Frame: Over 12 months ]

    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 :
  1. 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. [ Time Frame: Over 12 months ]
    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.

  2. 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. [ Time Frame: Over 12 months ]
    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.

  3. 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. [ Time Frame: Over 12 months ]
    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.

  4. 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. [ Time Frame: Over 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298541


Contacts
Layout table for location contacts
Contact: Jana Ivanidze, MD/Ph.D 212-746-6000 jai9018@med.cornell.edu
Contact: Gabriela Madera 212-746-9924 gmm4001@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Medical College of Cornell University
New York, New York, United States, 10021
Contact: Jana Ivanidze, MD/Ph.D    212-746-6000    jai9018@med.cornell.edu   
Contact: Gabriela Madera    212-746-9924    gmm4001@med.cornell.edu   
Principal Investigator: Jana Ivanidze, MD/Ph.D         
Sponsors and Collaborators
Weill Medical College of Cornell University
Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Jana Ivanidze, MD/Ph.D Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04298541    
Other Study ID Numbers: 19-10021002
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Edotreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action