99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: 99mTc-MIRC213


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-MIRC213 Dosimetry study<br>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. | Drug: 99mTc-MIRC213<br>* 99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans<br>|
| Experimental: 99mTc-MIRC213 wholebody and SPECT/CT scan<br>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. | Drug: 99mTc-MIRC213<br>* 99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPECT/CT, HER2