[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
Recruiting · NCT07020806 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, Davis
View the official record on ClinicalTrials.gov →Interventions studied
[68Ga]Ga DOTA-5G
What this trial is about
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
Who can take part
Age range
18 Years to 89 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- University of California Davis - Sacramento, California, United States