Breast Cancer, Breast Cancer, HER2-Expression
Conditions
Brief 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.
Detailed description
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.
Interventions
RADIATION18F-HER2 Affibody PET scan
HER2 Affibody, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-HER2 Affibody PET scan.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV | 2 years | The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET |
Countries
China
Contacts
CONTACTZhenguang Wang, Doctoral Degree
Outcome results
None listed