Application of 68Ga-Pentixafor PET/CT for Thymoma

Thymoma Clinical Trial

Official title:

Chemokine Receptor CXCR4-targeting PET Imaging for Thymoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086327
• Other study ID #: PUMCH-CXCR4-thymoma
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Thymoma
• Thymus Neoplasms

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