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 molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.
Age ≥18 years
Patients referred for and meeting institutional criteria for a [68Ga]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).
Pregnant and breast-feeding patients.
Patients unwilling or unable to undergo a second PET/CT.
Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).
This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
Cohort
Prospective
68Ga-DOTATATE PET/CT
Diagnostic testEach study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
18F-AmBF3-TATE PET/CT
Diagnostic testEach study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. After a 60 minute uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE
To assess the non-inferiority of \[18F\]AmBF3TATE compared to the standard-of-care \[68Ga\]DOTATATE
Number of patients in whom one or more target lesions are detected by the core readers.
Number of patients in whom \[18F\]AmBF3TATE and \[68Ga\]DOTATATE detects disease.
Standard Uptake Values (SUV) for lesions detected
To assess uptake values (SUV) for tumour lesions (SUVmax, SUVpeak, tumour to background ratio for liver, blood, kidney and lung, contrast and signal to noise ratio).
CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment
To assess image quality using semi-quantitative (contrast-to-noise and tumour-to-background) and subjective indices
Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement
To assess reader confidence and inter-rater agreement
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
