Back to results99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
99mTc-MIRC213
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring SPECT/CT, HER2
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.
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
99mTc-MIRC213 Dosimetry study
99mTc-MIRC213 wholebody and SPECT/CT scan
Arm Description
about 6 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan at 5min、20min、40min、60min、90min、120min、180min、240min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.
About 30 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan 1 \2\3h later and underwent SPECT/CT scan at 2h.
Outcomes
Primary Outcome Measures
Dosimetric distribution of radiopharmaceuticals
Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software
Standardized uptake value
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.
Secondary Outcome Measures
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Full Information
NCT ID
NCT05622240
First Posted
November 14, 2022
Last Updated
November 18, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05622240
Brief Title
99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
Official Title
99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
SPECT/CT, HER2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
99mTc-MIRC213 Dosimetry study
Arm Type
Experimental
Arm Description
about 6 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan at 5min、20min、40min、60min、90min、120min、180min、240min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.
Arm Title
99mTc-MIRC213 wholebody and SPECT/CT scan
Arm Type
Experimental
Arm Description
About 30 patients were injected with 11.1-14 (MBq) per kilogram body weight of 99mTc-MIRC213 in one dose intravenously and underwent wholebody scan 1 \2\3h later and underwent SPECT/CT scan at 2h.
Intervention Type
Drug
Intervention Name(s)
99mTc-MIRC213
Intervention Description
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans
Primary Outcome Measure Information:
Title
Dosimetric distribution of radiopharmaceuticals
Description
Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software
Time Frame
2 months
Title
Standardized uptake value
Description
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 year
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang, Dr
Phone
+8615584172170
Email
zhzwrx.123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, Dr
Phone
+8619800370331
Email
pumch_jacobwong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, Dr
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, Dr
Phone
+8619800370331
Email
pumch_jacobwong@163.com
12. IPD Sharing Statement
Learn more about this trial
99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer
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