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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• (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.

Locations
United States
California
University of California Davis
RECRUITING
Sacramento
Contact Information
Primary
Julie Sutcliffe, PhD
jlsutcliffe@ucdavis.edu
916-734-5536
Time Frame
Start Date: 2025-11-18
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
Experimental: [68Ga]Ga-DOTA-5G PET/CT imaging
Following an injection of up to 5 mCi of \[68Ga\]Ga DOTA-5G patients will be undergo PET/CT scans.
Related Therapeutic Areas
Sponsors
Collaborators: Society of Nuclear Medicine and Molecular Imaging, Dr. Helen K Chew, University of California Davis, Dr. Cameron Foster, University of California Davis
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov

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