An interventional study of 68Ga-XHER2 PET/CT in Solid Tumor (Excluding CNS), HER2 and PET / CT, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Other
The objective of this study is to evaluate the feasibility of 68Ga-XHER2 PET/CT as a noninvasive imaging approach for assessing HER2 expression in patients with solid tumors and to investigate the correlation between tracer uptake and pathological HER2 expression.
68Ga-XHER2 is a novel HER2-targeted PET radiotracer with potential applications in the noninvasive assessment of HER2 expression across various solid tumors. In this study, patients with different types of solid tumors will undergo 68Ga-XHER2 PET/CT imaging. Tumor uptake will be quantified using the maximum standardized uptake value (SUVmax). HER2 expression in tumor tissues will be assessed by immunohistochemistry (IHC). The correlation between 68Ga-XHER2 uptake and pathological HER2 expression will be analyzed to evaluate the feasibility of 68Ga-XHER2 PET/CT for noninvasive assessment of HER2 expression in solid tumors.
The First Affiliated Hospital of Xiamen University is the lead sponsor of 118 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Each subject receives a single intravenous injection of 68Ga-XHER2 and undergoes PET/CT imaging within the specified time.
Drug: 68Ga-XHER2 PET/CT
Each participant will receive a single intravenous injection of 68Ga-XHER2, a novel HER2-targeted PET probe, followed by PET/CT imaging.
Evaluate the feasibility of PET/CT imaging with 68Ga-XHER2 for the non-invasive assessment of HER2 expression in various cancer types.
Tumor HER2 expression analysis in a fresh biopsy sample will be correlated to 68Ga-XHER2 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-XHER2PET/CT.
Time frame: 1month
Description of 68Ga-XHER2 uptake by measuring standardized uptake value (SUV) in various types of tumors
Standardized uptake value (SUV) of 68Ga-XHER2 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Time frame: 1 month
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital of Xiamen University →