This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
(Ability to understand and willingness to sign a written informed consent document.
Men and women age ≥ 18 yrs
Confirmed presence of metastatic/advanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST
Available archival tumor tissue
Pregnant and lactating women
Prisoners
Concurrent malignancy of a different histology that could confound imaging interpretation.
Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
Single group
[68Ga]Ga DOTA-5G
DrugPatients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
The 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.
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.
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University of California, Davis
Lead sponsor
Dr. Helen K Chew, University of California Davis
Collaborator
Dr. Cameron Foster, University of California Davis
Collaborator
Society of Nuclear Medicine and Molecular Imaging
Collaborator
