CXCR4-related DiseaseNCT06690736
Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases
A study testing CXCR4 PET/CT Imaging in people with CXCR4-related Disease and Tumor, run by Tianjin Medical University at 3 sites in China.
Trial summary
To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CXCR4-related Disease, Tumor, Positron Emission Tomography
- What is being tested?
- CXCR4 PET/CT Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2022to 1 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
- 18F-FDG PET/CT within two weeks
- signed written consent.
Who cannot join
- pregnancy
- breastfeeding
- known allergy against Pentixafor
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
Qiang Xie, PhD, +8613721108043, ahxq1980@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Haonan Yu, MD, +8613821000597, dreamadam@126.com
About this study
To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.
Read the detailed description
Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.
- Conditions
- CXCR4-related Disease, Tumor, Positron Emission Tomography, Metastasis
- Being tested
- CXCR4 PET/CT Imaging
- Keywords
- PET/CT, Chemokine receptor 4, Pentixafor, Pentixather
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4 PET/CT ImagingDiagnostic test
Also called 68/18F-Pentixafor, 68/18F-Pentixather
Each subject receive a single intravenous injection of 68Ga/18F-Pentixafor/Pentixather, and undergo PET/CT imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| CXCR4 PET/CT Imaging | Experimental | Intravenous injection of one dose of 2-5 mCi 68Ga/18F-Pentixafor/Pentixather. Tracer doses of radiotracers will be used to image lesions by PET/CT Receives: Diagnostic Test: CXCR4 PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 30 days
Secondary outcomes (1)
Diagnostic efficacy
The sensitivity, specificity and accuracy of FAPI PET/CT were calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Mar 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CXCR4-related DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Responsible party
- Principal investigator, Shaobo Yao, PhD, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690736
- Sponsor's protocol ID
- TJMUGH-02
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases
- ClinicalTrials.gov ID
- NCT06690736
- Acronym / sponsor ID
- TJMUGH-02
- Conditions
- CXCR4-related Disease, Tumor, Positron Emission Tomography, Metastasis
- Keywords
- PET/CT, Chemokine receptor 4, Pentixafor, Pentixather
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Nov 2024 (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.
To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.
Detailed description
Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXCR4 PET/CT Imaging | Experimental | Diagnostic Test: CXCR4 PET/CT ImagingIntravenous injection of one dose of 2-5 mCi 68Ga/18F-Pentixafor/Pentixather. Tracer doses of radiotracers will be used to image lesions by PET/CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
- 18F-FDG PET/CT within two weeks
- signed written consent.
Key exclusion criteria (3 listed)
- pregnancy
- breastfeeding
- known allergy against Pentixafor
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 |
|---|---|---|
| CXCR4 PET/CT ImagingAlso: 68/18F-Pentixafor, 68/18F-PentixatherEach subject receive a single intravenous injection of 68Ga/18F-Pentixafor/Pentixather, and undergo PET/CT imaging within the specificed time. | Diagnostic test | CXCR4 PET/CT Imaging |
Primary outcome
Standardized uptake value (SUV)
Time frame: 30 days
Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
1 secondary outcome
Diagnostic efficacy
Time frame: 30 days
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 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for CXCR4-related Disease
RecruitingObservational study
The Role of Cxcr4Hi neutrOPhils in InflueNza
Influenza, Acute Respiratory Distress Syndrome
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CXCR4 PET/CT Imaging in people with CXCR4-related Disease and Tumor, run by Tianjin Medical University at 3 sites 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 3 inclusion and 3 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Haonan Yu, MD (+8613821000597, dreamadam@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: 30 days). 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 8 Sep 2026.