Overview
This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Description
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.
Eligibility
Inclusion Criteria:
- (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)
- Available archival tumor tissue
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3,Platelet count ≥ 100,000/mm3, Hemoglobin ≥ 8 g/dL.
- Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, creatinine clearance >60 mL/min.
- Anticipated life expectancy ≥ 3 months
- Able to remain motionless for up to 30-60 minutes per scan.
Exclusion Criteria:
- 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)