18F-AmBF3-TATE PET/CT for Imaging NET Patients
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Observational

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.
    

Intervention name(s): 18F-AmBF3-TATE PET/CT; Routine blood draw
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after [18F]AmBF3-TATE administration.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This will be a prospective, open-label trial in patients with proven/documented SSTR
        positive tumors.