NCT07020806PHASE1Recruiting
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
University of California, Davis
Start Date
11/18/2025
Completion Date
6/1/2027
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).
Detailed 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 Criteria
Age Range: 18 years to 89 years
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 (ULN), Total bilirubin ≤ 2 times ULN, eGFR \>60 mL/min/1.73m\*2
* 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)
Interventions
DRUG
[68Ga]Ga DOTA-5G
Conditions
Metastatic Lobular Breast Carcinoma
Locations
University of California Davis
Sacramento, California 95817
United States