NCT07020806 · University of California, Davis
[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
What this study is about
This is a forward-looking study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).
View original scientific description
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 outcome measures
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
Time frame: 2 hours from time of injection
To assess the ability of \[68Ga\]Ga DOTA-5G PET/CT imaging to detect lesions. Following injection of \[68Ga\]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by \[68Ga\]Ga DOTA-5G PET/CT imaging, positive vs. negative based on if SUVmax \>2-fold above normal brain, bone, lung, or liver of \[68Ga\]Ga DOTA-5G in at least one lesion assessed by \[68Ga\]Ga DOTA-5G PET/CT and identified on \[18F\]-FDG PET/CT diagnostic imaging.
Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0
Time frame: Up to 7 days from time of injection
To evaluate the safety and tolerability of \[68Ga\]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Concurrent malignancy of a different histology that could confound imaging interpretation.
- Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
Where
- Sacramento, California
Collaborators
Dr. Helen K Chew, University of California Davis, Dr. Cameron Foster, University of California Davis, Society of Nuclear Medicine and Molecular Imaging
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations