Clinical trial
Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
Name
PUMCH-ABH2
Description
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.
Trial arms
Trial start
2023-03-20
Estimated PCD
2023-12-30
Trial end
2024-01-30
Status
Recruiting
Treatment
99mTc-ABH2
Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.
Arms:
99mTc-ABH2 SPECT/CT
Size
40
Primary endpoint
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
1 year
Eligibility criteria
Inclusion Criteria:
* clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form
Exclusion Criteria:
* pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-01-08
1 organization
1 product
1 indication
Organization
Peking Union Medical College HospitalProduct
99mTc-ABH2Indication
Breast Cancer