Breast Cancer
Conditions
Brief summary
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
Detailed description
PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.
Interventions
DIAGNOSTIC_TESTDrug: 68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of breast cancer by PET/CT.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* breast cancer patients highly suggested by ultrasound or histologically confirmed; * 68Ga-P16-093 PET/CT and 18F-FDG within two weeks; * signed written consent.
Exclusion criteria
* known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance | through study completion, an average of 1 year | comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| standardized uptake value (SUV) of tumor | through study completion, an average of 1 year | comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG |
Countries
China
Contacts
Primary ContactXinyu Lu
Backup ContactZhaohui Zhu
Outcome results
None listed