ClinicalTrials.gg
RecruitingNCT06086327Updated Oct 17, 2023

Application of 68Ga-Pentixafor PET/CT for Thymoma

An Early Phase 1 interventional study of 68Ga-Pentixafor in Thymoma, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-17.

Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Jun 2023, registered Oct 2023).
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Chemokine receptor CXCR4 was expressed in T cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of thymoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, distinguish evaluation for thymoma.

Read the detailed description

Thymoma is 1 rare type of tumor developed on the thymic epithelium; patients with thymoma also might have myasthenia gravis (MG). Because of the scarcity and complexity of MG-associated thymoma, its pathogenesis and etiology still remain unclear nowadays. The expression of C-X-C chemokine receptor type 4 (CXCR4) is absent or low in most healthy tissues but highly expressed in various types of tumors. CXCR4 might contribute to the clinical cancer progression, and CXCR4 could be a valuable prognostic biomarker in the therapy of MG-associated thymoma.

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Conditions studied

  • Thymoma

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03

In context

Thymoma

133 studies on the registry are indexed under Thymoma; 37 are open to participants now.

This study's planned enrollment of 100 is above the median of 44 across 108 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 thymoma patients
  • signed written consent.

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
  • any medical condition that in the opinion of the investigator,may
  • significantly interfere with study compliance.
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    68Ga-Pentixafor, PET/CT

    Inject 68Ga-Pentixafor and then perform PET/CT scan.

    Drug: 68Ga-Pentixafor

Interventions

  • Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions of thymoma by PET/CT.

    Also known as: 68Ga-CXCR4

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What researchers measure

Primary outcomes

  1. SUVmax and SUVmean

    SUVsof focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVs of the blood pool and muscle are defined as the background activity on the condition that there is no focally hypermetabolic disease.

    Time frame: through study completion, an average of 1.5 years

Secondary outcomes

  1. Diagnostic value

    Diagnostic value of 68Ga-Pentixafor PET/CT for thymoma in comparison with 18F-FDG PET/CT or CT or MRI.

    Time frame: through study completion, an average of 1.5 years

  2. Diagnostic value in special type of thymoma

    Diagnostic value of 68Ga-Pentixafor PET/CT in special type thymoma (A\\AB\\B\\C subtypes)

    Time frame: through study completion, an average of 1.5 years

  3. Diagnostic value in thymoma and other masses

    Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass.

    Time frame: through study completion, an average of 1.5 years

  4. CXCR4 expression and SUV

    Correlation between CXCR4 expression and SUV in PET

    Time frame: through study completion, an average of 1.5 years

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Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
    Beijing, Beijing 100730, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Dec 2024, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2023
First posted
Oct 17, 2023
StartActual
Jun 22, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Oct 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06086327
Responsible party
Sponsor
First posted
Oct 17, 2023
Start date
Jun 22, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 17, 2023

Study contacts

Rongxi Wang
Contact
zhzwrx.123@163.com
+8615584172170
Zhaohui Zhu
Contact
13611093752@163.com
+8613611093752
Zhaohui Zhu
study chair · Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Oversight

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

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Studies of the drug tested here: 68Ga-pentixafor

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