This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
This is a phase I investigator-initiated study that will investigate \[68Ga\]Ga DOTA-5G in patients with metastatic/advanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period. We hypothesize that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) \[68Ga\]Ga DOTA-5G will be safe and well tolerated, and that c) \[68Ga\]Ga DOTA-5G PET/CT is more sensitive than 18F-FDG PET/CT at detecting lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
University of California Davis
Sacramento, California, United States
RECRUITINGThe ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
To assess the ability of \[68Ga\]Ga DOTA-5G PET/CT imaging to detect lesions. Following injection of \[68Ga\]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by \[68Ga\]Ga DOTA-5G PET/CT imaging, positive vs. negative based on if SUVmax \>2-fold above normal brain, bone, lung, or liver of \[68Ga\]Ga DOTA-5G in at least one lesion assessed by \[68Ga\]Ga DOTA-5G PET/CT and identified on \[18F\]-FDG PET/CT diagnostic imaging.
Time frame: 2 hours from time of injection
Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0
To evaluate the safety and tolerability of \[68Ga\]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0.
Time frame: Up to 7 days from time of injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.