Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases

Not Applicable

Recruiting

• Conditions: CXCR4-related Disease; Tumor; Positron Emission Tomography; Metastasis

• Registration Number: NCT06690736
• Lead Sponsor: Tianjin Medical University

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.

Detailed Description

Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
• 18F-FDG PET/CT within two weeks
• signed written consent.

Exclusion Criteria

• pregnancy
• breastfeeding
• known allergy against Pentixafor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of FAPI PET/CT were calculated.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China