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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06086327
Other study ID # PUMCH-CXCR4-thymoma
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 22, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Peking Union Medical College Hospital
Contact Rongxi Wang
Phone +8615584172170
Email zhzwrx.123@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 1.5 years
Secondary Diagnostic value 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
Secondary Diagnostic value in special type of thymoma 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
Secondary Diagnostic value in thymoma and other masses Diagnostic value of 68Ga-Pentixafor PET/CT in thymoma and other anterior mediastinal mass. through study completion, an average of 1.5 years
Secondary CXCR4 expression and SUV Correlation between CXCR4 expression and SUV in PET through study completion, an average of 1.5 years
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