PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-Her2-affibody.
- Who it may be relevant to
- Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors
Overview
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
- Drug 68Ga-Her2-affibody
68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.
Primary outcome measures
- The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer [Time frame: 1 year]
Secondary outcome measures (3)
- The dosimetry of 68Ga-Her2-affibody [Time frame: 1 year]
- Quantitative evaluation of 68Ga-Her2-affibody [Time frame: 1 year]
- Correlation with pathological expression [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
\- patients with confirmed or suspected cancer; Signed written informed consent
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Publications
- Gao Y, Yin L, Duan X, Fu Z, Liu Q, Chen J, Xin L, Zhu X, Xiang H, Xu L, Ye J, Liu M. HER2-targeted PET/CT imaging provides potential biomarkers for differentiating HER2-zero, -low, and -positive breast cancer. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4525-4538. doi: 10.1007/s00259-025-07220-3. Epub 2025 May 8. PMID 40338302
Identifiers
NCT: NCT06289517 · 68Ga-Her2-affibody