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

Early Phase 1

Recruiting

• Conditions: Malignant Tumour
• Interventions: Drug: 68Ga-dPNE; Drug: 18F-FDG

• Registration Number: NCT06995976
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief 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.

Study Timeline

• Study Start: 2025-03-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Signed informed consent and be able to follow up.

Exclusion Criteria

Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
SUV of tumors	Through study completion, an average of 3 months	Compare the SUV of tumors between 68Ga-dPNE PET/CT and 18F-FDG PET/CT.

Secondary Outcome Measures

Name	Time	Method
Diagnostic value	Through study completion, an average of 3 months	Sensitivity and specificity of 68Ga-dPNE in patients with various types of cancer and compare it with 18F-FDG PET/CT.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China