68Ga PET/CT Imaging in Breast Cancer Patients
68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started Nov 2022
Shorter than P25 for phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
November 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 18, 2022
November 1, 2022
1.1 years
November 14, 2022
November 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
through study completion, an average of 1 year
Secondary Outcomes (1)
standardized uptake value (SUV) of tumor
through study completion, an average of 1 year
Study Arms (1)
68Ga-P16-093 and 18F-FDG scan
EXPERIMENTALWithin 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- breast cancer patients highly suggested by ultrasound or histologically confirmed;
- Ga-P16-093 PET/CT and 18F-FDG within two weeks;
- signed written consent.
You may not qualify if:
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 18, 2022
Study Start
November 15, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
November 18, 2022
Record last verified: 2022-11