[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
University of California, Davis
Summary
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
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
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) or PERCIST * 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…
Interventions
- Drug[68Ga]Ga DOTA-5G
Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
Location
- University of California DavisSacramento, California