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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT Diagnostic Imaging | Each subject will have two PET/CT scans, one using 68Ga-DOTATATE and the other using 18F-AmBF3-TATE. The 18F-AmBF3-TATE radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 68Ga-DOTATATE is considered standard care and has been approved by Health Canada. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 2 weeks of the scan |
| Standard Uptake Values (SUV) for lesions detected |
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Inclusion Criteria:
Exclusion Criteria:
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This will be a prospective, open-label trial in patients with suspected or proven SSTR positive tumors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Project Manager | Contact | 604-675-8000 | 7649 | MITclinicaltrials@bccancer.bc.ca |
| Administrative Research Manager | Contact | 604-877-6000 | 2818 | MITclinicaltrials@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ian Alberts, MBBS MD PhD FEBNM | BC Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
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|
| 18F-AmBF3-TATE PET/CT | Diagnostic Test | 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. |
|
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).
| within 2 weeks of the scan |
| 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 | within 2 weeks of the scan |
| 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 | within 2 weeks of the scan |
| Frequency of adverse events (AE) and serious adverse events (SAE). | To compare the safety of both tracers | Immediately post-scan |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D010673 | Pheochromocytoma |
| D010235 | Paraganglioma |
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018278 | Carcinoma, Neuroendocrine |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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