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

August 26, 2026 updated by: Weill Medical College of Cornell University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 85 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
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.
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.
Over 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
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.
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.
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.
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.
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.
Over 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jana Ivanidze, MD/Ph.D, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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