Programmed Cell Death Ligand 1 PET/CT in Various PD-L1-Re... | NCT07618936

Studies
Programmed Cell Death Ligand 1 PET/CT in Various PD-L1-Related Disease Patients

NCT07618936

Sponsor

Tianjin Medical University

Status

Recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

PD-L1 Gene Mutation
PD-L1 Gene Amplification
PD-L1-related Disease
Positron Emission Tomography

Interventions

Single Group Assignment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jun 1, 2031Estimated

Completion Date

Jun 1, 2031Estimated

First Submitted Date

May 24, 2026

First Submission Date that Met QC Criteria

May 24, 2026

First Posted Date

Jun 1, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2026

Last Update Posted Date

Jun 1, 2026Actual

Name	Class
Tianjin Medical University General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Subjects with various FAP-related disease patients underwent 68Ga/18F-PD-L1 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-PD-L1 PET/CT were calculated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Single Group Assignment	Diagnostic Test	Each subject receive a single intravenous injection of 68Ga/18F-DMP10 or other PDL1 tracers, and undergo PET/CT imaging within the specificed time.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Diagnostic efficacy	The sensitivity, specificity and accuracy of PD-L1 PET/CT were calculated.	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haonan Yu, MD	Contact	+8613821000597		dreamadam@126.com

Overall Officials

Name	Affiliation	Role
Haonan Yu, MD	Tianjin Medical University General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of University of Science and Technology of China	Recruiting	Hefei	Anhui	230000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided