Breast Cancer
Conditions
Keywords
SPECT/CT, HER2 imaging
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-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.
Detailed description
99mTc-HPArk2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-HPArk2 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-HPArk2 SPECT/CT in stratifying breast cancer.
Interventions
DRUG99mTc-HPArk2
99mTc-HPArk2 were injected into the patients before the SPECT/CT scans
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value of 99mTc-HPArk2 in breast tumor | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events collection | 1 week | Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed |
Countries
China
Outcome results
None listed