Imaging HER2-Positive Cancer with 68Ga-HER2 Affibody PET/CT
68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
This study is testing a new imaging method to see if it can better identify HER2-positive cancers in patients, helping to improve treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05535621 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of 68Ga-HER2 Affibody PET imaging in assessing HER2 status in patients with various HER2-positive cancers, including breast, gastrointestinal, head and neck, bladder, lung, and uterine tumors. The study addresses the limitations of traditional biopsy methods, which may yield false-negative results due to the heterogeneous expression of HER2. By using a noninvasive imaging tracer that binds to HER2 receptors, the investigators hope to provide a more accurate assessment of HER2 status, which can change over time. The study is conducted at Tongji Hospital in Wuhan, Hubei.
Who should consider this trial
Good fit: Ideal candidates include patients with clinically diagnosed HER2-positive tumors who can provide informed consent.
Not a fit: Patients who are pregnant, have renal failure, or suffer from claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could enable more accurate identification of patients who would benefit from HER2-targeted therapies.
How similar studies have performed: Previous studies have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2-positive breast and gastric cancers, indicating potential for success in broader applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed consent Exclusion Criteria: * Pregnant women; renal failure (serum Cr\>3mg/dl); Patients with claustrophobia
Where this trial is running
Wuhan, Hubei
- TongjiHospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Zhu Xiaohua, Dr — Tongji Hospital
- Study coordinator: Zhu Xiaohua, Dr
- Email: evazhu@vip.sina.com
- Phone: 13971513770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.