Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06995976

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malignant Tumour Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-dPNE

Drug

Intravenous injection of 68Ga-dPNE. 68Ga-dPNE PET/CT will be used to detect tumors.

18F-FDG

Drug

Intravenous injection of 18F-FDG.18F-FDG PET/CT will be used to detect tumors.

Primary outcomes

  1. SUV of tumors

    Time frame: Through study completion, an average of 3 months

    Compare the SUV of tumors between 68Ga-dPNE PET/CT and 18F-FDG PET/CT.

Secondary outcomes

  1. Diagnostic value

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Lin, MD

CONTACT

[email protected]

+86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.