Using PET imaging to evaluate HER2 expression in breast cancer patients after neoadjuvant therapy
Al18F-HER2-BCH PET/CT to Predict Response in Breast Patients Treated With ADC Therapy
This study is testing a special imaging technique to see if it can help doctors understand how well breast cancer patients are responding to treatment after they’ve received neoadjuvant therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06909604 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the predictive and prognostic value of F-18 labeled HER2 Affibody PET imaging in patients with breast cancer who have received neoadjuvant therapy. By evaluating HER2 expression through advanced imaging techniques, the study seeks to provide insights into treatment responses and outcomes. The approach involves administering a molecular PET radionuclide to visualize HER2 expression levels in tumors, which may help tailor future treatment strategies for patients. The study is conducted at Peking University Cancer Hospital & Institute and involves collaboration with other medical institutions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed HER2 positive or suspicious positive breast tumors who are undergoing neoadjuvant therapy.
Not a fit: Patients with significant hepatic or renal dysfunction, those who are pregnant, or individuals with claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment responses in breast cancer patients, leading to more personalized and effective therapies.
How similar studies have performed: Other studies utilizing PET imaging for HER2 expression in breast cancer have shown promising results, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged ≥18 years old; ECOG 0 or 1; 2. Patients with HER2 positive or low tumors; 3. Receives neoadjuvant therapy 4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions; 5. Life expectancy \> 3 months - Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refused to join the clinical research; 5. Suffering from claustrophobia or other mental disorders; 6. Any other situation that researchers considered it unsuitable to participate in the trial.
Where this trial is running
Beijing
- Peking University Cancer Hospital & Institute — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyi Guo, PhD
- Email: 15833916752@163.com
- Phone: 010-88196495
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.