68Ga PET/CT Imaging in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Drug: 68Ga-P16-093
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-P16-093 and 18F-FDG scan
Arm 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.
Outcomes
Primary Outcome Measures
Diagnostic performance
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
Secondary Outcome Measures
standardized uptake value (SUV) of tumor
comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG
Full Information
NCT ID
NCT05622227
First Posted
November 14, 2022
Last Updated
November 14, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05622227
Brief Title
68Ga PET/CT Imaging in Breast Cancer Patients
Official Title
68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-P16-093 and 18F-FDG scan
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Drug: 68Ga-P16-093
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic performance
Description
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
standardized uptake value (SUV) of tumor
Description
comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyu Lu
Phone
86-18813128336
Email
lslxysou@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu
Phone
86-13611093752
Email
13611093752@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Phone
86-13611093752
Email
13611093752@163.com
12. IPD Sharing Statement
Learn more about this trial
68Ga PET/CT Imaging in Breast Cancer Patients
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