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

NCT06916637 | Recruiting

• 1 other identifier: QDFY-NM-25006
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer, HER2-Expression

Outcome Measures

Primary Outcomes (1)

• SUV

  The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET

  2 years

Study Arms (1)

18F-HER2 Affibody PET scan

Radiation: 18F-HER2 Affibody PET scan

Interventions

18F-HER2 Affibody PET scan RADIATION

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.

18F-HER2 Affibody PET scan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for this clinical trial consists of adults aged 18 to 75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Participants must have a clinically or pathologically confirmed diagnosis of HER2 expression breast cancer or suspected HER2 expression breast cancer. A life expectancy of at least 12 weeks is required, along with the presence of at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All participants of reproductive potential must agree to use effective contraceptive methods throughout the trial and for six months after the last PET scan. Additionally, participants must be able to understand and voluntarily sign the informed consent form，demonstrating good compliance with the study protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenguang Wang, Doctoral Degree

CONTACT

+86-0532-82913318; wangzhenguang@qdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)