68Ga PET/CT Imaging in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622227
• Other study ID #: PekingUMCH-BCa093
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Peking Union Medical College Hospital
• Contact: Xinyu Lu
• Phone: 86-18813128336
• Email: lslxysou[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Drug: 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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