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

NCT04207762 | Completed

• 1 other identifier: H19-03674
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Biodistribution of 18F-AmBF3-TATE PET/CT in human subjects

  Measurement of radiotracer uptake at multiple time points following radiotracer injection. Calculation of radiation dosimetry using OLINDA 2.0 methodology. Determination of tumour uptake in terms of standardized uptake values and tumour/blood, tumour/liver and tumour/lung ratios (descriptive analysis). For accuracy determination, it is anticipated that only a subset of participants may have a complete gold standard for the determination of accuracy. The sensitivity, specificity and accuracy (along with the confidence interval) of 18F-AMBF3-TATE will be calculated for patients with an available gold standard. The proportion of participants with a complete gold standard is not yet known for this study.

  1 year

Secondary Outcomes (3)

• Number of participants with 18F-AmBF3-TATE - related adverse events as assessed by abnormal vital sign measurement.

  Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection

• Number of participants with self-reported 18F-AmBF3-TATE -related adverse event

  18-72 hours

• Total number of lesions per anatomic location identified by 18F-AmBF3-TATE PET/CT

  1 year

Study Arms (1)

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; Diagnostic Test: Routine blood draw

Interventions

18F-AmBF3-TATE PET/CT 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.

PET/CT Diagnostic Imaging

Routine blood draw DIAGNOSTIC_TEST

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

PET/CT Diagnostic Imaging

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This will be a prospective, open-label trial in patients with proven/documented SSTR positive tumors.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 23, 2019
• Study Start: June 9, 2020
• Primary Completion: September 21, 2020
• Study Completion: January 15, 2021
• Last Updated: January 20, 2021

Record last verified: 2019-12

Locations

CA (1)