Status:
RECRUITING
Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Breast Cancer
Breast Cancer, HER2-Expression
Eligibility:
All Genders
18-75 years
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 inc...
Detailed Description
Human epidermal growth factor receptor 2 (HER2) is a transmembrane receptor protein with tyrosine kinase activity that plays a crucial role in cell growth, activation, and proliferation. While minimal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06916637
Start Date
April 9 2025
End Date
December 1 2027
Last Update
April 30 2025
Active Locations (1)
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1
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000