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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)
* 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 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

Locations1 site

University of California Davis
Sacramento, California, 95817
Julie L Sutcliffe916-734-5536jlsutcliffe@ucdavis.edu

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