Clinical trial NCT04207762: 18F-AmBF3-TATE PET/CT for Imaging NET Patients
Official title: Evaluation of the Safety and Sensitivity of 18F-AmBF3-TATE PET/CT for Imaging NET Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

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.

Primary outcomes:
measure: Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with 18F-AmBF3-TATE - related adverse events as assessed by abnormal vital sign measurement.
timeFrame: Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection
measure: Number of participants with self-reported 18F-AmBF3-TATE -related adverse event
timeFrame: 18-72 hours
measure: Total number of lesions per anatomic location identified by 18F-AmBF3-TATE PET/CT
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
References: