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

Launched by THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique called 18F-HER2 Affibody PET, which is designed to help diagnose and monitor a type of breast cancer that expresses a protein called HER2. HER2 is important because it can influence how certain treatments work. The study aims to see how well this new imaging method can detect HER2-expressing breast cancer early, help stage the disease, and monitor how well treatments are working. This could lead to more personalized treatment plans for patients.

To participate in the trial, you need to be between 18 and 75 years old and have a confirmed diagnosis of HER2-expressing breast cancer or be suspected of having it. You should also be in generally good health and have a life expectancy of at least 12 weeks. Participants will need to commit to using effective contraception if they are capable of becoming pregnant. Throughout the trial, participants can expect to undergo PET scans that are designed to give clear images of the cancer. It's important to note that people with severe liver or kidney problems, pregnant or nursing women, and those who cannot lie flat for about half an hour may not be eligible to join.

Gender

ALL

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.