[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)
NCT ID: NCT07020806
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-06-30
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[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.
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prisoners
* Concurrent malignancy of a different histology that could confound imaging interpretation.
* Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
18 Years
89 Years
ALL
No
Sponsors
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Dr. Helen K Chew, University of California Davis
UNKNOWN
Dr. Cameron Foster, University of California Davis
UNKNOWN
Society of Nuclear Medicine and Molecular Imaging
UNKNOWN
University of California, Davis
OTHER
Responsible Party
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Julie L. Sutcliffe, Ph.D
Professor
Principal Investigators
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Julie Sutcliffe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California Davis
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2213682
Identifier Type: -
Identifier Source: org_study_id
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