68Ga PET/CT Imaging in Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Drug: 68Ga-P16-093


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-P16-093 and 18F-FDG scan<br>Within 1 week, each patient underwent 68Ga-P16-093 and 18F-FDG PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively. | Diagnostic Test: Drug: 68Ga-P16-093<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance | comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |