PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression
- Conditions
- Neoplasms
- Interventions
- Drug: 68Ga-Her2-affibody
- Registration Number
- NCT06289517
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
- Detailed Description
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- patients with confirmed or suspected cancer; Signed written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-Her2-affibody 68Ga-Her2-affibody Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.
- Primary Outcome Measures
Name Time Method The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer 1 year the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT
- Secondary Outcome Measures
Name Time Method Quantitative evaluation of 68Ga-Her2-affibody 1 year Analyze Her2 expression at the imaging level in combination with Her2 expression
Correlation with pathological expression 1 year Analyze Her2 expression at the imaging level in combination with Her2 expression in pathological specimens
The dosimetry of 68Ga-Her2-affibody 1 year Research on the dose distribution of 68Ga-Her2-affibody in cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China