68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
NCT ID: NCT05535621
Last Updated: 2023-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-12-18
2025-12-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Xiaohua Zhu
Professor
Principal Investigators
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ZHU XIAOHUA, DR
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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TongjiHospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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xiaohua zhu, Dr.
Role: primary
References
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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.
Other Identifiers
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TJ-IRB20211129
Identifier Type: -
Identifier Source: org_study_id
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