RecruitingPhase 1NCT07020806
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
Sponsor
University of California, Davis
Enrollment
30 participants
Start Date
Nov 18, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 89 Years
Inclusion Criteria9
- (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 Criteria4
- 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
Patients will be injected with up to 5 mCi of \[68Ga\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07020806