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RecruitingNCT06690736Updated Sep 8, 2026

Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases

An interventional study of CXCR4 PET/CT Imaging in CXCR4-related Disease, Tumor and Positron Emission Tomography, sponsored by Tianjin Medical University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Primary conditionNeoplasm MetastasisRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neoplasm Metastasis
Why
  1. The study's listed conditions name Neoplasm Metastasis, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Tianjin Medical University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Mar 2022, registered Nov 2024).
  • Started Mar 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • CXCR4-related Disease
  • Tumor
  • Positron Emission Tomography
  • Metastasis

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Keywords

  • PET/CT
  • Chemokine receptor 4
  • Pentixafor
  • Pentixather
03

In context

Neoplasm Metastasis Reclassified

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.

Compared within Neoplasm Metastasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
  • 18F-FDG PET/CT within two weeks
  • signed written consent.

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    CXCR4 PET/CT Imaging

    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

    Diagnostic Test: CXCR4 PET/CT Imaging

Interventions

  • Diagnostic testCXCR4 PET/CT Imaging

    Each subject receive a single intravenous injection of 68Ga/18F-Pentixafor/Pentixather, and undergo PET/CT imaging within the specificed time.

    Also known as: 68/18F-Pentixafor, 68/18F-Pentixather

06

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

    Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

    The sensitivity, specificity and accuracy of FAPI PET/CT were calculated.

    Time frame: 30 days

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06690736
Lead sponsor
Tianjin Medical University
Collaborators
Tianjin Medical University General Hospital
Responsible party
Shaobo Yao, PhD (Prof., Tianjin Medical University) — Principal investigator
First posted
Nov 15, 2024
Start date
Mar 1, 2022
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Haonan Yu, MD
Contact
dreamadam@126.com
+8613821000597
Shaobo Yao, PhD
Contact
yaoshaobo008@163.com
+8615122570279

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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