NCT06844110

Brief Summary

68Ga-DOTA-dPNE PET/CT imaging was performed on patients with malignant tumors to observe the binding of lesions with the tracer and evaluate the expression of CD73. At the same time, correlation analysis was performed combined with relevant clinical indicators to evaluate the efficacy of 68Ga-DOTA-dPNE in the diagnosis and guidance of malignant tumor patients, and predict the response of targeted therapy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

August 5, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

February 19, 2025

Last Update Submit

July 31, 2025

Conditions

Tumor Immunity

Outcome Measures

Primary Outcomes (1)

  • Lesion SUV value

    After the completion of the PET scan

Study Arms (1)

Malignant tumor

EXPERIMENTAL
Drug: 68GA-DOTA-dPNE

Interventions

68GA-DOTA-dPNEDRUG

Intravenous administration of 68GA-DOTA-dPNE tracer

Malignant tumor

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • : Age: ≥18 years, expected survival ≥12 weeks 2: Without radiotherapy and chemotherapy, surgery or biopsy is feasible to obtain pathological diagnosis 3: Standard Solid Tumor Response Evaluation Criteria (RECIST) version 1.1 with at least one measurable target lesion 4: Obtain written informed consent and be able to follow up

You may not qualify if:

  • \- 1: Severe liver and kidney dysfunction. 2: Women who are planning to conceive, pregnant, or breastfeeding, as well as those planning to have children during the study period, are not eligible to participate in this research. Women of childbearing potential must use effective contraception throughout the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PUMCH

Dongcheng, Beijing Municipality, 100730, China

RECRUITING

Study Officials

  • Xianzhong Zhang, PhD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhao Jia

CONTACT

18548703382jiachenhao24@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion

December 30, 2025

Study Completion

March 30, 2026

Last Updated

August 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)