68Ga DOTA-5G PET/CT imaging for metastatic invasive lobular breast cancer
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
This Phase I trial will test whether a new PET tracer called 68Ga DOTA-5G can safely find cancer sites and pick up more disease than standard 18F-FDG PET/CT in adults with metastatic or advanced invasive lobular breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT07020806 on ClinicalTrials.gov |
What this trial studies
This is a prospective Phase I investigator-initiated imaging study enrolling 30 patients with metastatic or advanced invasive lobular breast cancer over 24 months. Participants will undergo PET/CT imaging with 68Ga DOTA-5G, with comparisons made to standard 18F-FDG PET/CT to compare lesion detection. The study will monitor safety and tolerability of the tracer and record imaging sensitivity against RECIST or PERCIST-measurable disease. Eligibility requires measurable metastatic disease, available archival tumor tissue, ECOG ≤2, and basic hematologic and renal function criteria.
Who should consider this trial
Good fit: Adults (age ≥18) with confirmed metastatic or advanced invasive lobular breast cancer, measurable disease, available archival tumor tissue, ECOG performance status 0–2, and adequate blood and kidney function are ideal candidates.
Not a fit: Patients with early-stage disease, concurrent cancers that would confound imaging, pregnant or lactating women, or those who cannot undergo PET/CT (for example due to weight limits) are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the tracer could improve detection of lobular breast cancer metastases and help clinicians make more informed treatment decisions.
How similar studies have performed: While other 68Ga-labeled tracers have shown success in imaging different cancers, using 68Ga DOTA-5G specifically for invasive lobular breast cancer is a novel, early-phase application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sacramento, California
- University of California Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Julie Sutcliffe, PhD — University of California, Davis
- Study coordinator: Julie Sutcliffe, PhD
- Email: jlsutcliffe@ucdavis.edu
- Phone: 916-734-5536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.