Application of 68Ga-Pentixafor PET/CT for Thymoma

October 11, 2023 updated by: Peking Union Medical College Hospital

Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • suspected or confirmed untreated thymoma patients
  • signed written consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-Pentixafor, PET/CT
Inject 68Ga-Pentixafor and then perform PET/CT scan.
Drug: 68Ga-Pentixafor
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.
Other Names:
  • 68Ga-CXCR4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax and SUVmean
Time Frame: through study completion, an average of 1.5 years
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.
through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: through study completion, an average of 1.5 years
Diagnostic value of 68Ga-Pentixafor PET/CT for thymoma in comparison with 18F-FDG PET/CT or CT or MRI.
through study completion, an average of 1.5 years
Diagnostic value in special type of thymoma
Time Frame: through study completion, an average of 1.5 years
Diagnostic value of 68Ga-Pentixafor PET/CT in special type thymoma (A\AB\B\C subtypes)
through study completion, an average of 1.5 years
Diagnostic value in thymoma and other masses
Time Frame: through study completion, an average of 1.5 years
Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass.
through study completion, an average of 1.5 years
CXCR4 expression and SUV
Time Frame: through study completion, an average of 1.5 years
Correlation between CXCR4 expression and SUV in PET
through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaohui Zhu, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 11, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-CXCR4-thymoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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