Clinical trials / NCT06916637
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Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer

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…

ClinicalTrials.gov IDNCT06916637
PhaseNot Applicable
Enrollment40
SponsorThe Affiliated Hospital of Qingdao University
Age18 Years
SexALL
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Conditions studied

Breast Cancer, Breast Cancer, HER2-Expression

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.