An interventional study of 68Ga-Her2-affibody in Neoplasms, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.
Drug: 68Ga-Her2-affibody
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Also known as: Her2 specific PET imaging
The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT
Time frame: 1 year
The dosimetry of 68Ga-Her2-affibody
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
Time frame: 1 year
Quantitative evaluation of 68Ga-Her2-affibody
Analyze Her2 expression at the imaging level in combination with Her2 expression
Time frame: 1 year
Correlation with pathological expression
Analyze Her2 expression at the imaging level in combination with Her2 expression in pathological specimens
Time frame: 1 year
Plan to share: No
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Peking University First Hospital