68Ga-XHER2 PET/CT imaging to see HER2 in solid tumors
Official title: 68Ga-XHER2 PET/CT for Noninvasive Assessment of HER2 Expression Across Solid Tumors
Run by The First Affiliated Hospital of Xiamen University · NCT07885436 · Data updated 2026-11-12
A noninvasive PET/CT imaging test using 68Ga-XHER2 is being tried to see if it reflects HER2 levels in solid tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Status | Recruiting |
| Started | October 22, 2026 |
| Main results expected | October 22, 2027 |
| Study ends | October 22, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07885436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with suspected, newly diagnosed, or previously treated solid tumors who are scheduled for standard imaging and 68Ga-XHER2 PET/CT and can consent.
✕Probably not a fit
Patients whose tumors do not show HER2 expression or do not take up the tracer may not benefit from this imaging test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests a new HER2-targeted radiotracer, 68Ga-XHER2, for PET/CT imaging across various solid tumors. Tumor uptake will be measured with SUVmax and compared to HER2 expression measured by immunohistochemistry on tissue samples. The goal is to determine whether 68Ga-XHER2 PET/CT can reliably indicate HER2 status without invasive biopsy. Enrollment includes adults with suspected, newly diagnosed, or previously treated solid tumors who will have both standard imaging and the new PET/CT performed.
Why it matters
Potential benefit: If successful, this imaging approach could provide a noninvasive way to assess HER2 status across tumors.
How similar studies have gone: Prior HER2-targeted imaging research has shown promise, but this particular tracer and approach are exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients (aged 18 years or older) * patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report) * patients who had scheduled both standard-of-care imaging and 68Ga-XHER2 PET/CT scans * patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee Exclusion Criteria: * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Where it's running
-
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China Recruiting
Study contacts
- Study coordinator: Liang Zhao, MD, PhD
- Email: wzhaoliang01@163.com
- Phone: 18818350620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.