HER2-positive Breast Cancer
Conditions
Keywords
Her2-positive, Metastatic breast cancer, Positron-Emission Tomography
Brief summary
To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of \[131I\]/\[68Ga\]SGMIB-ZT-199.
Interventions
RADIATION68Ga/131I-SGMIB-ZT-199
68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry | about 24hours from time of injection | To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from \[131I\]SGMIB-ZT-199, assessed by PET/SPECT imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | From administration of [131I]SGMIB-ZT-199 until 1 week after injection | Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0 |
Countries
China
Contacts
Primary ContactYihui Guan, MD
Outcome results
None listed