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NCT07915297
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Conditions: Metastatic Breast Cancer
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Luminance Biosciences Inc
Location: Icon Cancer Center Nedlands Washington
Summary
This is a prospective study using \[68Ga\]Ga DOTA-5G PET/CT imaging in patients diagnosed with metastatic breast cancer (BC).
Eligibility Criteria
Inclusion Criteria:
* Ability to understand and willingness to sign a written informed consent document.
* Men and women age ≥ 18 yrs
* Confirmed presence of metastatic breast cancer
* Eastern Cooperative Oncology Group Performance Status ≤ 2
* Hematologic parameters defined as:
* Absolute neutrophil count (ANC) ≥ 1x 109 /L,
* Platelet count ≥ 100x 109 /L,
* Hemoglobin ≥ 80 g/L.
* Blood chemistry levels defined as:
* AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN),
* Total bilirubin ≤ 2 times ULN,
* Creatinine ≤ 2 times ULN.
* 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(\>450lbs)
Source: ClinicalTrials.gov (NCT07915297). StuddyBuddy aggregates publicly available trial information.