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Diagnostic Imaging for Metastatic Lobular Breast Cancer with [68Ga]Ga DOTA-5G

This study is testing a new imaging agent called [68Ga]Ga DOTA-5G to see how well it can find tumors in people with metastatic or advanced invasive lobular breast cancer (LBC). You would receive an injection of [68Ga]Ga DOTA-5G and then have PET/CT scans. Researchers want to see if this new imaging method is safe and better at detecting tumors than current methods. To join, you must be at least 18 years old, have confirmed metastatic/advanced LBC, and have available tumor tissue. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an investigational study (Phase I) that aims to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive an injection of [68Ga]Ga DOTA-5G and have imaging scans at 1 and 2 hours after the injection. Your safety will be monitored for up to 7 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 7 days after the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07020806

[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)

Recruiting
PHASE1Ages 18–89InterventionalDiagnostic
University of California, Davis
~30 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:[68Ga]Ga DOTA-5G

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions
Measured over 2 hours from time of injection
+1 more outcome measured

Conditions

Metastatic Lobular Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Julie Sutcliffe, PhD · PRINCIPAL_INVESTIGATOR · University of California, Davis

Who to contact

Julie Sutcliffe, PhD
[email protected]
916-734-5536
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

(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

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)

What this trial measures

  • The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions2 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 5.0Up 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.