Medullary Thyroid Carcinoma, Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors
Conditions
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 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.
Interventions
DIAGNOSTIC_TEST68Ga-DOTATATE PET/CT
Each 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. The participant will rest in a comfortable chair for 60 minutes. After this 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.
DIAGNOSTIC_TEST18F-AmBF3-TATE PET/CT
Each 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. The participant will rest in a comfortable chair for 60 minutes. After this 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.
Sponsors
British Columbia Cancer Agency
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE | Periprocedural | To assess the non-inferiority of \[18F\]AmBF3TATE compared to the standard-of-care \[68Ga\]DOTATATE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients in whom one or more target lesions are detected by the core readers. | within 2 weeks of the scan | Number of patients in whom \[18F\]AmBF3TATE and \[68Ga\]DOTATATE detects disease. |
| Standard Uptake Values (SUV) for lesions detected | within 2 weeks of the scan | 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 | within 2 weeks of the scan | 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 | within 2 weeks of the scan | To assess reader confidence and inter-rater agreement |
| Frequency of adverse events (AE) and serious adverse events (SAE). | Immediately post-scan | To compare the safety of both tracers |
Countries
Canada
Contacts
CONTACTResearch Project Manager
CONTACTAdministrative Research Manager
PRINCIPAL_INVESTIGATORIan Alberts, MBBS MD PhD FEBNM
BC Cancer
Outcome results
None listed