Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorThe First Affiliated Hospital of Xiamen University
Academic / other
Locations1 site (Xiamen, Fujian)
StatusRecruiting
StartedOctober 22, 2026
Main results expectedOctober 22, 2027
Study endsOctober 22, 2027
Registry record updatedOctober 21, 2026
Trial IDNCT07885436 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.