NCT06995976

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Malignant Tumour

Outcome Measures

Primary Outcomes (1)

  • SUV of tumors

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

    Through study completion, an average of 3 months

Secondary Outcomes (1)

  • Diagnostic value

    Through study completion, an average of 3 months

Study Arms (2)

68Ga-dPNE PET/CT

EXPERIMENTAL

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

Drug: 68Ga-dPNE

18F-FDG PET/CT

EXPERIMENTAL

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

Drug: 18F-FDG

Interventions

68Ga-dPNEDRUG

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

68Ga-dPNE PET/CT
18F-FDGDRUG

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

18F-FDG PET/CT

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent and be able to follow up.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Weibing Miao, MD

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

+86-0591-87981618miaoweibing@126.com

Rong Lin, MD

CONTACT

+86-0591-87981619linrong1214@foxmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)