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

NCT ID: NCT04207762

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2021-01-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PET/CT Diagnostic Imaging

Each subject will have a PET/CT scan, using 18F-AmBF3-TATE. 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.

18F-AmBF3-TATE PET/CT

Intervention Type: DIAGNOSTIC_TEST

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.

Routine blood draw

Intervention Type: DIAGNOSTIC_TEST

Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after \[18F\]AmBF3-TATE administration.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

All subjects:

• Participants with newly diagnosed or documented neuroendocrine tumours (NET), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-FDG, 18F-FDOPA or 68Ga-DOTATOC/DOTATATE scan) or scintigraphy (with 111In-pentetreotide imaging).
• ECOG performance status of 2 or less.

Exclusion Criteria

• Pregnancy
• Medically unstable (eg. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
• Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
• Patients with baseline ALT or AST higher than 5× ULN or 250 U/L.
• Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR >1.2, or platelet count below the lower limit of normal (typically <150 000/μL.
• Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BC Cancer

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H19-03674

Identifier Type: -

Identifier Source: org_study_id