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Trial Title:
68Ga PET/CT Imaging in Breast Cancer Patients
NCT ID:
NCT05622227
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Drug: 68Ga-P16-093
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.
Arm group label:
68Ga-P16-093 and 18F-FDG scan
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu
Phone:
86-13611093752
Email:
13611093752@163.com
Start date:
November 15, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622227
