68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2021
CompletedFirst Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 13, 2023
February 1, 2023
3 years
September 7, 2022
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SUVmax
SUVmax
1 year
Eligibility Criteria
patients with HER2-Positive tumor
You may qualify if:
- patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed consent
You may not qualify if:
- Pregnant women; renal failure (serum Cr\>3mg/dl); Patients with claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
TongjiHospital
Wuhan, Hubei, 430030, China
Related Publications (1)
Zou 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: 39951137DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
ZHU XIAOHUA, DR
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
December 18, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2025
Last Updated
February 13, 2023
Record last verified: 2023-02