NCT04207762

18F-AmBF3-TATE PET/CT for Imaging NET Patients

Evaluation of the Safety and Sensitivity of 18F-AmBF3-TATE PET/CT for Imaging NET Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of special molecules called somatostatin receptors (SSTR). Somatostatin receptor scintigraphy and conventional imaging are used to detect NETs. This study proposes 18F-AmBF3-TATE positron emission tomography/computed tomography (PET/CT) is superior to current imaging techniques. The goal is to evaluate the biodistribution and safety of 18F-AmBF3-TATE PET/CT for neuroendocrine tumour imaging.

Detailed description

Each subject will have a PET/CT scan using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. After providing informed written consent subjects will complete a medical history questionnaire. Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of 18F-AmBF3-TATE . Eighteen to seventy-two hours after 18F-AmBF3-TATE administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire. Follow-up Assessments The following information will be collected up to 12 months following the PET/CT scans: Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-AmBF3-TATE PET/CT	Blood pressure, heart rate, and oxygen saturation levels and EKG monitoring (vital signs) will be recorded prior to the injection and at three other stages of the scan visit. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged.
DIAGNOSTIC_TEST	Routine blood draw	Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after \[18F\]AmBF3-TATE administration.

Timeline

• Start date: 2020-06-09
• Primary completion: 2020-09-21
• Completion: 2021-01-15
• First posted: 2019-12-23
• Last updated: 2021-01-20

Locations

1 site across 1 country: Canada