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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07915297). StuddyBuddy aggregates publicly available trial information.