Application of 68Ga-Pentixafor PET/CT for Thymoma

Early Phase 1

Recruiting

• Conditions: Thymoma
• Interventions: Drug: 68Ga-Pentixafor

• Registration Number: NCT06086327
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-22
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-Pentixafor, PET/CT	68Ga-Pentixafor	Inject 68Ga-Pentixafor and then perform PET/CT scan.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)
CXCR4 expression and SUV	through study completion, an average of 1.5 years	Correlation between CXCR4 expression and SUV in PET
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China