Using 18F-HER2 Affibody PET Imaging for HER2-Positive Breast Cancer
Official title: Clinical Study on the Application of 18F-HER2 Affibody PET Imaging in HER2-Expressing Breast Cancer
Run by The Affiliated Hospital of Qingdao University · NCT06916637 · Data updated 2026-11-12
This study is testing a new imaging method using a special protein to see if it can help doctors better diagnose and monitor breast cancer that has the HER2 protein.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Status | Recruiting |
| Started | April 9, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06916637 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-75 with confirmed or suspected HER2-expressing breast cancer and at least one measurable target lesion.
✕Probably not a fit
Patients with severe hepatic or renal dysfunction, pregnant or lactating women, or those with claustrophobia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of 18F-labeled HER2 Affibody PET imaging in diagnosing and monitoring breast cancer that expresses the HER2 protein. By utilizing a novel engineered protein that binds to HER2, the study aims to provide high-contrast imaging that can assist in early detection, clinical staging, and treatment response monitoring. The approach seeks to offer a non-invasive alternative to traditional biopsy methods, allowing for better personalized treatment strategies for patients with HER2-expressing breast cancer.
Why it matters
Potential benefit: If successful, this imaging technique could lead to more accurate diagnoses and tailored treatment plans for patients with HER2-positive breast cancer.
How similar studies have gone: While this approach is innovative, similar imaging techniques have shown promise in other studies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China Recruiting
Study contacts
- Study coordinator: Zhenguang Wang, Doctoral Degree
- Email: wangzhenguang@qdu.edu.cn
- Phone: +86-0532-82913318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.