NCT06995976

Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Furthermover, we conducted a comparative analysis of 68Ga-dPNE and 18F-FDG imaging to assess both the radiation dosimetry and diagnostic efficacy of 68Ga-dPNE.

Detailed description

The boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. CD73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. Notably, CD73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-dPNE, and performed a head-to-head comparison with 18F-FDG PET/CT scans in patients with various cancers.

Conditions

• Malignant Tumour

Interventions

Type	Name	Description
DRUG	68Ga-dPNE	Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors.
DRUG	18F-FDG	Intravenous injection of 18F-FDG.18F-FDG PET/CT will be used to detect tumors.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: China