NCT06162988

PET Imaging of 68Ga-NOTA-H006 in Malignancy

A Study to Evaluate 5T4 Expression in Malignant Tumors Using 68Ga-NOTA-H006

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: YiHui Guan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages. Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	68Ga-NOTA-H006 is injected intravenously with a dose of 1.8 MBq[0.05MCi]/kg.	68Ga-NOTA-H006：PET imaging； 18F-FDG：PET imaging

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-01
• Completion: 2028-12-01
• First posted: 2023-12-08
• Last updated: 2023-12-08

Locations

1 site across 1 country: China