Clinical trial · Interventional
PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression
A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-Her2-affibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-Her2-affibody
- description
- Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging.
- interventionNames
- Drug: 68Ga-Her2-affibody
Primary outcomes (1)
- measure
- The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer
- timeFrame
- 1 year
- description
- the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT
Secondary outcomes (3)
- measure
- The dosimetry of 68Ga-Her2-affibody
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- patients with confirmed or suspected cancer; Signed written informed consent Exclusion Criteria: \-
References
Publications (1)
- DERIVEDGao 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