The study focuses on individuals diagnosed with Primary breast cancer and evaluates a special imaging test that uses a tiny amount of a radioactive substance to create detailed pictures of the body. The radioactive substance, known as [⁶⁸Ga]Ga-HKG301, is provided in the test product AAA514 and is given through an intravenous line. The images are obtained with a combined scanner called PET/CT, which merges two types of pictures to show both the structure and activity of tissues.

The purpose of the study is to determine how well this imaging test can identify the original location of the cancer and any spread, as well as to assess its ability to detect cancer that may return after treatment. Participants will receive an injection of the radioactive substance, wait a short period for it to circulate, and then undergo the scan. A follow‑up scan may be performed later to see any changes. “Staging” means finding the size and spread of cancer at diagnosis, while “restaging” refers to checking again after therapy. “Sensitivity” describes the test’s ability to correctly find cancer when it is present, “specificity” means correctly showing no cancer when it is absent, “predictive values” indicate how likely the results are to be correct, and “accuracy” reflects the overall correctness of the test.

The scan results will be compared with the tissue analysis that doctors perform after surgery to see if they match. The study will also look at whether the imaging changes the doctor’s view of the cancer stage, leads to different treatment choices, or reveals unexpected findings. Throughout the study, safety checks will be carried out to ensure that the injection and scanning procedure are well tolerated.