Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||19 Years and Over|
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.
- - Pregnancy - Medically unstable (eg.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|British Columbia Cancer Agency|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
: 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.
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.