Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
18F-HER2 Affibody PET scan
RadiationHER2 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: 18F-HER2 Affibody PET scan1 intervention
Trial outcomes
Primary outcomes
1
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov