68Ga-XHER2 PET/CT for HER2 Assessment

NCT07885436 | Recruiting

• 1 other identifier: XMYY-2026KY273
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor (Excluding CNS); HER2; PET / CT

Keywords

solid tumor; HER2; PET/CT

Outcome Measures

Primary Outcomes (1)

• 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.

  1month

Secondary Outcomes (1)

• Description of 68Ga-XHER2 uptake by measuring standardized uptake value (SUV) in various types of tumors

  1 month

Study Arms (1)

68Ga-XHER2

EXPERIMENTAL

Each subject receives a single intravenous injection of 68Ga-XHER2 and undergoes PET/CT imaging within the specified time.

Drug: 68Ga-XHER2 PET/CT

Interventions

68Ga-XHER2 PET/CT DRUG

Each participant will receive a single intravenous injection of 68Ga-XHER2, a novel HER2-targeted PET probe, followed by PET/CT imaging.

68Ga-XHER2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with pregnancy
• the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Central Study Contacts

Liang Zhao, MD, PhD

CONTACT

18818350620; wzhaoliang01@163.com

Haojun Chen, MD, PhD

CONTACT

86 18659285282; leochen0821@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 22, 2026
• Primary Completion (Estimated): October 22, 2027
• Study Completion (Estimated): October 22, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)