Recruiting
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
ClinicalTrials.gov IDNCT07020806
PhasePHASE1
Enrollment30
SponsorUniversity of California, Davis
Age18 Years
SexALL
Conditions studied
Metastatic Lobular Breast Carcinoma
About this study
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
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.
Primary outcomes
- The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions (2 hours from time of injection)
- Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0 (Up to 7 days from time of injection)
Eligibility information
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)
Study locations
- University of California Davis, Sacramento, California 95817 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.