drugset / Trial / NCT07589101

5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors

NCT07589101

Not yet recruiting 20 enrolled Peking University Cancer Hospital & Institute
NaSingle-groupOpen-labelDiagnostic

Summary

This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors. The 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread. In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.

Timeline

Start
2026-06-01
Primary completion
2027-06-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-FDG Diagnostic / imaging agent
Subject 68Ga-MY Diagnostic / imaging agent