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Not yet recruiting NCT04298541

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

Phase II Interventional Meningioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ga-68- DOTATATE, Ga-68-DOTATOC.
Who it may be relevant to
Registry conditions: Meningioma. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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.

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. [Time frame: 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]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Weill Cornell Medical College of Cornell University — New York

Identifiers

NCT: NCT04298541 · 19-10021002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗