NCT07618936

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-PD-L1 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PD-L1-related disease patients

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
61mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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 Progress1%
Jun 2026Jun 2031

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

May 24, 2026

Last Update Submit

May 24, 2026

Conditions

Keywords

PET/CTPD-L1DMP10

Outcome Measures

Primary Outcomes (1)

  • Standardized uptake value (SUV)

    Standardized uptake value (SUV) of PD-L1 for each target lesion of subject or suspected primary tumor or/and metastasis.

    30 days

Secondary Outcomes (1)

  • Diagnostic efficacy

    30 days

Study Arms (1)

Diagnostic Test: Single Group Assignment

Each subject receive a single intravenous injection of 68Ga/18F-DMP10 or other PD-L1 tracers, and undergo PET/CT imaging within the specificed time.

Diagnostic Test: Single Group Assignment

Interventions

Each subject receive a single intravenous injection of 68Ga/18F-DMP10 or other PDL1 tracers, and undergo PET/CT imaging within the specificed time.

Diagnostic Test: Single Group Assignment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PD-L1 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may qualify if:

  • (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PD-L1 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

  • (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Study Officials

  • Haonan Yu, MD

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 1, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations