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Trial Title:
99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
NCT ID:
NCT05622240
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
SPECT/CT
HER2
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
99mTc-MIRC213
Description:
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and
SPECT/CT scans
Arm group label:
99mTc-MIRC213 Dosimetry study
Arm group label:
99mTc-MIRC213 wholebody and SPECT/CT scan
Summary:
This is an open-label single photon emission tomography/computed tomography (SPECT/CT)
study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients.
A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213
will be injected intravenously. Visual and semiquantitative method will be used to assess
the SPECT/CT images.
Detailed description:
99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine
the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and
to compare its diagnostic value with routine immunohistochemistry (IHC) pathological
staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast
cancer cell surface, might help for targeted therapy with monoclonal antibody such as
trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer.
The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients in suspicion of breast cancer by mammography or ultrasonography,and being
able to provide basic information and sign the written informed consent form
Exclusion Criteria:
- The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or
liver failure, inability to fulfill the study, and undergoing any preceding local or
systemic therapies that might interfere with HER2 binding.
Gender:
Female
Minimum age:
N/A
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, Dr
Phone:
+8619800370331
Email:
pumch_jacobwong@163.com
Start date:
September 7, 2022
Completion date:
December 31, 2023
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/NCT05622240
