Life sciences · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · September 21, 2026
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Phase EARLY_PHASE1 Trial.
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Registry record from ClinicalTrials.gov (NCT06411678). This is a study registration, not published results. Lead sponsor: Peking Union Medical College Hospital. Recruitment status: RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: DRUG: 68GA-DOTA-dPNE. Primary outcome measures: The evaluation of diagnostic performance of 68Ga-DOTA-dPNE PET in breast cancer , through study completion, an average of 1 year. Brief summary: The investigators plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study in breast cancer patients to observe the binding of the tracer to tumor lesions and evaluate CD73 expression. As part of the study design, a subset of patients will initially undergo dynamic PET/CT imaging to evaluate the safety profile and pharmacokinetic distribution of the radiotracer in vivo. Subsequently, static PET/CT imaging will be performed on additional patients to assess the diagnostic effectiveness of 68Ga-DOTA-dPNE. Imaging results will be correlated with relevant clinical indicators to evaluate the potential of this tracer in diagnosing breast cancer, guiding therapeutic decisions, and predicting responses to targeted therapies.