Breast Cancer Clinical Trial
Official title:
68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic performance | comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG | through study completion, an average of 1 year | |
Secondary | standardized uptake value (SUV) of tumor | comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG | through study completion, an average of 1 year |
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