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

University of California (UC) Davis

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Lobular Breast Carcinoma

Treatments: Drug: [68Ga]Ga DOTA-5G

Study type: Interventional

Funder types: Other

Identifiers

NCT07020806

2213682

Details and patient eligibility

About

This is a prospective study using [68Ga]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic/advanced invasive lobular breast cancer (LBC).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

[68Ga]Ga-DOTA-5G PET/CT imaging

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga DOTA-5G