99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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