This is a prospective single arm cohort study designed to evaluate the diagnostic ability of 68Ga-FAPI-PET/CT scan in determining likely tissue of origin in Cancer of Unknown Primary (CUP) patients not identified by standard of care. Patients with CUP will be either treatment naïve or starting second-line treatment.
Cancers of unknown primary (CUP) account for 3-5% of all malignancies. The prognosis of patients diagnosed with CUP is poor, with a median overall survival of 9-12 months. Despite improvements in conventional diagnostic processes, the tissue of origin (ToO) is identified in \<30% of CUP patients. PET/CT is increasingly used to determine the ToO, with the most commonly used PET radiotracer being the glucose analogue fluorine-18 fluorodeoxyglucose (FDG). Although PET/CT can change CUP patient management and identify primary sites, FDG has limited sensitivity for detecting some cancers, such as CUP. It has been reported that fibroblast activation protein (FAP) is highly expressed in some tumours, including CUP. 68Ga-FAPI (experimental drug) is a radiotracer that can specifically bind to FAP, and may enable the primary cancer site to be viewed using PET imaging. It is hypothesised that the use of 68Ga-FAPI-PET/CT will increase likely ToO diagnosis from 30% with current standard of care to 60%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
FAPI-46 is a small molecular radiopharmaceutical that binds to the fibroblast activated protein on cancer associated fibroblasts. Gallium-68 (68Ga) is a positron-emitting isotope with a half-life of 68 minutes.
PET with the investigational tracer 68Ga-FAPI-46 with accompanying low-dose CT for anatomical localisation
Bendigo Health
Bendigo, Victoria, Australia
RECRUITINGPeter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGSouth West Healthcare
Warrnambool, Victoria, Australia
NOT_YET_RECRUITINGThe proportion of patients in which a likely tissue of origin is identified using 68Ga-FAPI-PET/CT
The proportion of patients in which 68Ga-FAPI-PET/CT identifies a likely Tissue of Origin (ToO) beyond that identified by standard of care (SoC) testing.
Time frame: 12 months
Maximum Standard Uptake Value measured on 68Ga-FAPI-PET/CT
The average SUVmax of the 5 most intense lesions measured on 68Ga-FAPI-PET/CT based on the best overall response rate assessed via RECIST after commencement of systemic therapy.
Time frame: 12 months
The proportion of patients in which the choice of treatment is changed after the 68Ga-FAPI-PET/CT
The change in patient management/treatment pre- and post- 68Ga-FAPI-PET/CT.
Time frame: 12 months
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