Imaging method for breast cancer using targeted PET scans
Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer
This study is testing a new type of PET scan that targets specific proteins in breast cancer to see if it can help doctors better identify and understand the disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06715826 on ClinicalTrials.gov |
What this trial studies
This study aims to establish and optimize a PET/CT imaging method that targets Trop2 and HER2 in breast cancer patients. Enrolled participants will receive specific imaging probes and undergo scans to evaluate the distribution and uptake of these agents in tumors and normal tissues. The study will assess the diagnostic efficacy of these imaging agents by calculating various metrics such as sensitivity and specificity, and will also analyze the correlation between imaging results and protein expression levels. The ultimate goal is to determine the feasibility and preliminary diagnostic value of these targeted imaging techniques.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-75 with a histologically confirmed diagnosis or suspicion of breast cancer.
Not a fit: Patients who are pregnant, have severe hepatic or renal insufficiency, or have a recent history of serious surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of breast cancer diagnosis and improve treatment planning.
How similar studies have performed: Other studies using targeted imaging approaches have shown promise, suggesting potential success for this method as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-75 years old and of female gender； 2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging; 3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. Exclusion Criteria: 1. Pregnancy； 2. Severe hepatic and renal insufficiency; 3. History of serious surgery in the last month; 4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Where this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weijun Wei, Ph.D. & M.D.
- Email: wwei@shsmu.edu.cn
- Phone: 15000083153
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.