Imaging HER2-positive metastatic breast cancer using a new PET agent
Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
This study is testing a new imaging agent to see if it can help doctors better identify and treat HER2-positive metastatic breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Huashan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05982626 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a new imaging agent, 68Ga/131I-SGMIB-ZT-199, in patients with HER2-positive metastatic breast cancer. Participants will receive an injection of the agent, and the study will assess its biodistribution, radiation dosimetry, and uptake in tumor lesions. The goal is to improve diagnostic imaging for this specific type of breast cancer, potentially leading to better treatment planning and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 75 with confirmed HER2-positive metastatic breast cancer.
Not a fit: Patients with severe hepatic or renal insufficiency or those participating in other studies that involve radiation exposure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing HER2-positive metastatic breast cancer, leading to more tailored and effective treatment options for patients.
How similar studies have performed: While this approach is innovative, similar studies using targeted imaging agents have shown promise in improving cancer diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer patients. 1. Women aged between 18 and 75 years old. 2. Patients with breast cancer confirmed by histological examination or imaging. 3. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)). 4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities. 5. Patients of childbearing age can cooperate with contraception. 6. Willing and able to cooperate with all items of this study. Exclusion Criteria: * Subjects meeting any of the following criteria will be excluded from the study: 1. Severe hepatic or renal insufficiency; 2. Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study. 3. Participation in this study is considered unsuitable by other investigators. 4. Pregnant women and other groups unsuitable to receive radiation. 5. Alcohol allergy, etc.
Where this trial is running
Shanghai
- Huashan Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Fang Xie, PhD — Huashan Hospital
- Study coordinator: Yihui Guan, MD
- Email: guanyihui@hotmail.com
- Phone: 13764308300
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.