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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
SUV — 2 years The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
Trial sites (1)
Facility
City
Region
Status
Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
More The Affiliated Hospital of Qingdao University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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