RecruitingNCT06916637

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

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

40 participants

Start Date

Apr 9, 2025

Study Type

OBSERVATIONAL

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria6

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.

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.