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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET imaging agent called 18F-HER2 affibody that targets the HER2 protein, which is overexpressed in some breast cancers. Researchers want to see how accurately this scan can detect and locate HER2-expressing breast cancer tumors. **You may be eligible if...** - You are between 18 and 75 years old with an ECOG score of 0 or 1 - You have confirmed or suspected HER2-expressing breast cancer - Your expected survival is at least 12 weeks - You have at least one measurable lesion on imaging - You are willing to use effective contraception during the study and for 6 months after **You may NOT be eligible if...** - You have severe liver or kidney dysfunction - You are pregnant or breastfeeding - You are claustrophobic or have other conditions preventing a PET scan - You cannot lie flat for 30 minutes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

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NCT06916637


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