68Ga PET/CT Imaging in Breast Cancer Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Diagnostic Test: Drug: 68Ga-P16-093

Study type: Interventional

Funder types: Other

Identifiers

NCT05622227

PekingUMCH-BCa093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

68Ga-P16-093 and 18F-FDG scan

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Drug: 68Ga-P16-093