Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
6 participants
INTERVENTIONAL
2026-01-31
2027-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
DIAGNOSTIC
NONE
Study Groups
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Patients with Meningioma
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients planned for surgery - undergoing preoperative workup
* No contraindications to either radiotracer
Exclusion Criteria
* Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
18 Years
89 Years
ALL
No
Sponsors
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Cornell University
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Jana Ivanidze, MD/Ph.D
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical College of Cornell University
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-10021002
Identifier Type: -
Identifier Source: org_study_id
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