Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-HER2 Affibody PET scan.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Cancer, HER2-Expression. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Radiation 18F-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.
Primary outcome measures
- SUV [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Affiliated Hospital of Qingdao University — Qingdao
Identifiers
NCT: NCT06916637 · QDFY-NM-25006