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Application of 68Ga-Pentixafor PET/CT for Thymoma

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086327
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
18.3
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma
Actual Study Start Date :
Jun 22, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SUVmax and SUVmean [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.

    Secondary Outcome Measures

    1. Diagnostic value [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.

    2. Diagnostic value in special type of thymoma [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)

    3. Diagnostic value in thymoma and other masses [through study completion, an average of 1.5 years]

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

    4. CXCR4 expression and SUV [through study completion, an average of 1.5 years]

      Correlation between CXCR4 expression and SUV in PET

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College Beijing Beijing China 100730

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT06086327
    Other Study ID Numbers:
    • PUMCH-CXCR4-thymoma
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thymoma
    Thymus Neoplasms

    Study Results

    No Results Posted as of Oct 17, 2023