Clinical trial · Observational
68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
- 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)
The prevalence of HER2 alterations in pan-cancer indicates a broader range of application of HER2-targeted therapies. immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH) is currently the most commonly used method for evaluation of HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the chance for targeted therapy. Additionally, the HER2 status can change during the disease process. A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors. Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2 positive breast cancer and gastric cancer without any observed toxicity. However, studies are still insufficient and limited to breast cancer and gastric cancer. The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively assess HER2 status in metastatic or recurrent solid tumors including breast cancer, gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2 positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET will be determined.
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 |
|---|---|---|---|
| HER2-Positive Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- SUVmax
- timeFrame
- 1 year
- description
- SUVmax
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed consent Exclusion Criteria: * Pregnant women; renal failure (serum Cr\>3mg/dl); Patients with claustrophobia
References
Publications (1)
- DERIVEDZou S, Liu Z, Zhou J, Song S, Wang D, Zhu D, Cheng S, Cheng Z, Zhu Y, Yu T, Pan D, Yang M, Zhu X. Non-invasive assessment of HER2 expression in patients with urothelial carcinoma using [68Ga]Ga-HER2 affibody PET/CT imaging: preliminary clinical findings. Eur J Nucl Med Mol Imaging. 2025 Jul;52(8):2782-2791. doi: 10.1007/s00259-025-07142-0. Epub 2025 Feb 14. PMID 39951137