[⁶⁸Ga]Ga-HKG301 PET/CT for staging and restaging patients with primary breast cancer: a phase II study (FAPILOUS)

Condition studied

Primary breast cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT

Endpoint detail

The correlation between the response measures observed on [⁶⁸Ga]Ga-HKG301 PET/CT and the histopathological response, The influence of [⁶⁸Ga]Ga-HKG301 PET/CT on stage migration, alterations in treatment decisions, and incidental findings, Evaluate safety and tolerability of [⁶⁸Ga]Ga-HKG301