Using 99mTc-ABH2 SPECT/CT for diagnosing breast cancer
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
This study is testing a new imaging method to see if it can help detect HER2-positive breast cancer and its spread in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06194565 on ClinicalTrials.gov |
What this trial studies
This prospective study investigates the diagnostic performance of 99mTc-ABH2 SPECT/CT in detecting HER2-positive primary breast cancer and potential metastases. The study employs visual and semiquantitative methods to evaluate SPECT/CT images, comparing tumor imaging data with HER2 expression from biopsy samples analyzed through immunohistochemistry and fluorescent in situ hybridization. The findings may enhance screening and monitoring for targeted therapies, such as monoclonal antibodies like Trastuzumab.
Who should consider this trial
Good fit: Ideal candidates include individuals with clinically suspected primary breast cancer confirmed by mammography or ultrasonography who can provide informed consent.
Not a fit: Patients who are pregnant, lactating, or have impaired liver or kidney function, as well as those undergoing therapies that may interfere with HER2 binding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of breast cancer diagnosis and monitoring, leading to better-targeted treatments.
How similar studies have performed: While the specific use of 99mTc-ABH2 SPECT/CT is novel, similar imaging approaches have shown promise in enhancing breast cancer diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form Exclusion Criteria: * pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Hongli MD Jing — Peking Union Medical College Hospital
- Study coordinator: Yuwei Zhang
- Email: ywzhangwork@163.com
- Phone: +8618511071577
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.