Imaging Trop2 in Triple-negative Breast Cancer
99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer
This study is testing a new imaging method to see if it can help track a specific protein in patients with triple-negative breast cancer to better understand their tumors and improve treatment choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | radiation, gosatuzumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06104085 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a new nuclear medicine molecular probe, 99mTc-MY6349, to monitor the expression of Trop2 in patients with triple-negative breast cancer using SPECT/CT imaging. Trop2 is a receptor that is highly expressed in many cancers, including breast cancer, and is associated with poor prognosis. The trial aims to assess the effectiveness of this imaging technique in identifying Trop2 levels in systemic tumors, which could help in understanding tumor behavior and guiding treatment decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 18 to 80 with suspected or confirmed triple-negative breast cancer.
Not a fit: Patients with severe comorbidities or those who have recently received significant ionizing radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could provide critical insights into tumor biology and improve treatment strategies for patients with triple-negative breast cancer.
How similar studies have performed: While the use of imaging techniques in cancer diagnostics is well-established, the specific application of 99mTc-MY6349 for Trop2 in triple-negative breast cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged between 18 and 80 years old. * Patients with suspected or definite diagnosis of triple-negative breast cancer. * Patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer. * Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period. Exclusion Criteria: * Suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases. * Claustrophobia. * In the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50mSv. * Pregnant or lactating women. * Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month. * There is any situation in which the conductor of this study believes that any aspect related to this experiment may cause harm or be potentially harmful.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Li Huo — Peking Union Medical College Hospital
- Study coordinator: Li Huo
- Email: huoli@pumch.cn
- Phone: 86-13910801986
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.