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

NCT ID: NCT06995976

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Tumour

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

68Ga-dPNE PET/CT

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

Group Type EXPERIMENTAL

68Ga-dPNE

Intervention Type DRUG

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

18F-FDG PET/CT

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

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-dPNE

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

Intervention Type DRUG

18F-FDG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Weibing Miao, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Weibing Miao, MD

Role: CONTACT

+86-0591-87981618

Rong Lin, MD

Role: CONTACT

+86-0591-87981619

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Weibing Miao, MD

Role: primary

+86-0591-87981618

Rong Lin, MD

Role: backup

+86-0591-87981619

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FirstAHFujian-CD73

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tracer Targeting FAP PET Imaging in Patients
NCT05691894 UNKNOWN EARLY_PHASE1
68Ga-labeled NY105 PET Imaging in Patients
NCT05691881 UNKNOWN EARLY_PHASE1
68Ga-ICAM-1pep PET/CT in Cancer Patients
NCT04596670 RECRUITING EARLY_PHASE1