99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
- Conditions
- Breast Cancer
- Interventions
- Biological: 99mTc-ABH2
- Registration Number
- NCT03546478
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 99mTc-ABH2 SPECT/CT 99mTc-ABH2 The patients were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later.
- Primary Outcome Measures
Name Time Method T/B 1 year Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer
- Secondary Outcome Measures
Name Time Method Adverse events collection 1 week Adverse events within 1 week after the injection and scanning of patients will be followed and assessed
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China