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

19-10021002

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.

2024-05-01

2024-05-01

2025-05-01

Not yet recruiting

Early phase I

6

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.\n\nVisit 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.\n\nVisit 2 At least 24h and up to 4 weeks apart from Visit 1, patients will undergo 68Ga-DOTATOC PET/CT scan.\n\nFollow-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.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ESTIMATED'}}

2024-05-22