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[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
RECRUITINGPhase 1Sponsored by University of California, Davis
Actively Recruiting
PhasePhase 1
SponsorUniversity of California, Davis
Started2025-11-18
Est. completion2027-06
Eligibility
Age18 Years – 89 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07020806
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
Age: 18 Years – 89 YearsHealthy volunteers accepted
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)
Conditions3
Breast CancerCancerMetastatic Lobular Breast Carcinoma
Interventions1
Locations1 site
University of California Davis
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Actively Recruiting
PhasePhase 1
SponsorUniversity of California, Davis
Started2025-11-18
Est. completion2027-06
Eligibility
Age18 Years – 89 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07020806