Neoplasms
Conditions
Keywords
68Ga-Her2-affibody, PET/CT, Neoplasms
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.
Interventions
DRUG68Ga-Her2-affibody
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- patients with confirmed or suspected cancer; Signed written informed consent
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactLei Yin, Dr
Outcome results
None listed