NCT07020806 [68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
| NCT ID | NCT07020806 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Metastatic Lobular Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-11-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Julie Sutcliffe, PhD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT07020806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Metastatic Lobular Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07020806 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07020806 currently recruiting?
Yes, NCT07020806 is actively recruiting participants. Contact the research team at jlsutcliffe@ucdavis.edu for enrollment information.
Where is the NCT07020806 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT07020806 clinical trial?
NCT07020806 is sponsored by University of California, Davis. The principal investigator is Julie Sutcliffe, PhD at University of California, Davis. The trial plans to enroll 30 participants.