Solid Tumor (Excluding CNS)NCT07885436
68Ga-XHER2 PET/CT for HER2 Assessment
A study testing 68Ga-XHER2 PET/CT in people with Solid Tumor (Excluding CNS) and HER2, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor (Excluding CNS), HER2, PET / CT
- What is being tested?
- 68Ga-XHER2 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2026to 22 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Liang Zhao, 18818350620, wzhaoliang01@163.com
About this study
Official title: 68Ga-XHER2 PET/CT for Noninvasive Assessment of HER2 Expression Across Solid Tumors
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.
Read the detailed description
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.
- Conditions
- Solid Tumor (Excluding CNS), HER2, PET / CT
- Being tested
- 68Ga-XHER2 PET/CT
- Keywords
- solid tumor, HER2, PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-XHER2 PET/CTDrug
Each participant will receive a single intravenous injection of 68Ga-XHER2, a novel HER2-targeted PET probe, followed by PET/CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-XHER2 | Experimental | Each subject receives a single intravenous injection of 68Ga-XHER2 and undergoes PET/CT imaging within the specified time. Receives: Drug: 68Ga-XHER2 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start22 Oct 2026 (estimated)
- Primary completion22 Oct 2027 (estimated)
- Study completion22 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Excluding CNS)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885436
- Sponsor's protocol ID
- XMYY-2026KY273
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-XHER2 PET/CT for Noninvasive Assessment of HER2 Expression Across Solid Tumors
- ClinicalTrials.gov ID
- NCT07885436
- Acronym / sponsor ID
- XMYY-2026KY273
- Conditions
- Solid Tumor (Excluding CNS), HER2, PET / CT
- Keywords
- solid tumor, HER2, PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 22 Oct 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-XHER2 | Experimental | Drug: 68Ga-XHER2 PET/CTEach subject receives a single intravenous injection of 68Ga-XHER2 and undergoes PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients with pregnancy
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-XHER2 PET/CTEach participant will receive a single intravenous injection of 68Ga-XHER2, a novel HER2-targeted PET probe, followed by PET/CT imaging. | Drug | 68Ga-XHER2 |
Primary outcome
Evaluate the feasibility of PET/CT imaging with 68Ga-XHER2 for the non-invasive assessment of HER2 expression in various cancer types.
Time frame: 1month
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.
1 secondary outcome
Description of 68Ga-XHER2 uptake by measuring standardized uptake value (SUV) in various types of tumors
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-XHER2 PET/CT in people with Solid Tumor (Excluding CNS) and HER2, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Zhao, MD, PhD (18818350620, wzhaoliang01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of PET/CT imaging with 68Ga-XHER2 for the non-invasive assessment of HER2 expression in various cancer types. (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.