99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

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 diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description
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99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 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-ABH2 SPECT/CT in stratifying breast cancer.

Official Title
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99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: 99mTc-ABH2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female Exclusion Criteria: Pregnancy Breastfeeding Renal function: serum creatinine > 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Ages Eligible for Study
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Minimum Age: 29 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-ABH2 SPECT/CT<br>The patients were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later. | Biological: 99mTc-ABH2<br>* 99mTc-ABH2 were injected into the patients before the SPECT/CT scans<br>* Other names: 99mTc labelled HER2 affibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T/B | Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer | 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 will be followed and assessed | 1 week | 

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