68Ga PET/CT Imaging in Breast Cancer Patients

Phase 1

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05622227
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study Start: 2022-11-15
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	through study completion, an average of 1 year	comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China