clinical study on the application of 18f-her2 affibody pet imaging in her2-expressing breast cancer

Conditions: Breast Cancer; Breast Cancer, HER2-Expression

Summary: this study aims to evaluate the clinical utility of 18f-labeled her2 affibody pet for diagnosing and monitoring her2-expressing breast cancer. her2, a protein overexpressed in certain malignancies including breast cancer, serves as a critical biomarker for targeted therapies.the her2 affibody-an engineered 7 kda protein with nanomolar affinity for her2-leverages its rapid tumor penetration and clearance kinetics to achieve high-contrast pet imaging. this study aims to evaluate the diagnostic efficacy of 18f-her2 affibody pet in early detection, clinical staging, and treatment response monitoring, thereby providing novel imaging evidence to guide personalized therapeutic strategies for patients with her2-expressing breast cancer.

human epidermal growth factor receptor 2 (her2) is a transmembrane receptor protein with tyrosine kinase activity that plays a crucial role in cell growth, activation, and proliferation. while minimally expressed in normal tissues, her2 is highly expressed in various malignant tumors, especially breast cancer, making it a key target for breast cancer diagnosis and treatment.her2-positivity was defined with immunohistochemistry (ihc) 3+ or ihc 2+ followed by fluorescence in situ hybridization（fish） showing her2 amplification.her2-low was defined ihc 1+ or ihc 2+ with negative fish . conventional diagnostic approaches like biopsy are inherently invasive and lack the capability for longitudinal evaluation of her2 expression dynamics.the her2-targeted affibody molecule demonstrates superior diagnostic potential compared to traditional antibodies, attributed to its enhanced specificity, compact molecular structure enabling rapid biodistribution (achieving optimal blood clearance within 1-4 hours post-injection), and consequent high-contrast imaging capabilities. as a novel positron emission tomography (pet) tracer, 18f-her2 affibody holds promise for delivering precise, non-invasive quantification of her2 status. this study seeks to systematically assess the diagnostic accuracy of 18f-her2 affibody pet in tumor staging and treatment stratification, while concurrently investigating its prognostic value through longitudinal treatment response monitoring in breast cancer patients with her2-overexpressing tumors.

Eligibility criteria:
inclusion criteria: * age 18-75 years, ecog score 0 or 1. * clinically or pathologically confirmed diagnosis of patients with her2 expression breast cancer or suspected expression breast cancer. * life expectancy ≥ 12 weeks. * at least one measurable target lesion according to recist 1.1 criteria. * all participants of reproductive potential (regardless of gender) must commit to using effective contraceptive methods throughout the trial participation and for 6 months after the last pet scan. * ability to understand and voluntarily sign the informed consent form, with good compliance. exclusion criteria: * severe hepatic or renal dysfunction. * pregnant or lactating women, or women planning to become pregnant. * inability to lie supine for half an hour. * refusal to participate in this clinical study. * suffering from claustrophobia or other mental illnesses. * other conditions that the investigator deems unsuitable for participation in the trial.