NCT06770478

A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours

68Ga-MY6349 A Clinical Study of the Diagnostic Efficacy of PET/CT for Tumours of Epithelial Origin

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a study using an autocontrol approach, enrolling 40 patients with tumours of epithelial origin, who underwent 68Ga- MY6349 and 68Ga-PSMA/18F-FDG PET/CT imaging of patients with tumours of epithelial origin to compare the ability to diagnose, stage and monitor recurrence of tumours of epithelial origin using the pathological findings as the gold standard.

Conditions

• Tumour of Epithelial Origin
• 68Ga-MY6349

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-MY6349 PET/CT Scan	The imaging agent 68Ga-MY6349 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185\~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.

Timeline

• Start date: 2024-10-18
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-01-13
• Last updated: 2025-01-17

Locations

1 site across 1 country: China