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

Phase 1

Recruiting

• Conditions: Metastatic Lobular Breast Carcinoma
• Interventions: Drug: [68Ga]Ga DOTA-5G

• Registration Number: NCT07020806
• Lead Sponsor: University of California, Davis

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).

Detailed Description

This is a phase I investigator-initiated study that will investigate \[68Ga\]Ga DOTA-5G in patients with metastatic/advanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period.

We hypothesize that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) \[68Ga\]Ga DOTA-5G will be safe and well tolerated, and that c) \[68Ga\]Ga DOTA-5G PET/CT is more sensitive than 18F-FDG PET/CT at detecting lesions.

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)
• 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, creatinine clearance >60 mL/min.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]Ga-DOTA-5G PET/CT imaging	[68Ga]Ga DOTA-5G	Following an injection of up to 5 mCi of \[68Ga\]Ga DOTA-5G patients will be undergo PET/CT scans.

Primary Outcome Measures

Name	Time	Method
The ability of [68Ga]Ga DOTA-5G PET/CT imaging to detect lesions	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	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.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States