NCT04304066

Brief Summary

To use the molecular probe PET radionuclide (Ga-68 or F-18) WL12 peptide to detect the expression of PD-L1 in the primary and metastatic lesions in patients with solid tumor; to detect the expression heterogeneity of PD-L1 in the lesion and inter-lesions; to observe the change of PD-L1 expression in the course of treatment. To provide an approach for screening patients with high expression of PD-L1, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the Individualized antitumor treatment of targeted drugs.

Trial Health

55
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 Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

August 6, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

5.3 years

First QC Date

March 9, 2020

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • SUV

    The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)on PET/CT

    2 years

Study Arms (1)

Imaging cohort

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study).Study participants will undergo 18F-WL12 or 68Ga-WL12 PET/CT scans

Other: 18F-WL12 PET or 68Ga-WL12 PET

Interventions

WL12, labeled with PET radio-nuclide ( Ga-68 or F-18)will be used as a molecular imaging tracer for PET/CT scanning

Imaging cohort

Eligibility Criteria

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

You may qualify if:

  • \. Aged \>18 years old; ECoG 0 or 1;
  • \. Patients with solid tumors;
  • \. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
  • \. life expectancy \>=12 weeks.

You may not qualify if:

  • \. Significant hepatic or renal dysfunction;
  • \. Is pregnant or ready to pregnant;
  • \. Cannot keep their states for half an hour;
  • \. Refusal to join the clinical study;
  • \. Suffering from claustrophobia or other mental diseases;
  • \. Any other situation that researchers think it is not suitable to participate in the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shunlian Zhou

Beijing, China

Location

Related Publications (1)

  • Zhou X, Yan S, Li D, Zhu H, Liu B, Liu S, Zhao W, Yang Z, Wu N, Li N. Radiolabelled anti-PD-L1 peptide PET/CT in predicting the efficacy of neoadjuvant immunotherapy combined with chemotherapy in resectable non-small cell lung cancer. Ann Nucl Med. 2025 Apr;39(4):364-372. doi: 10.1007/s12149-024-02009-0. Epub 2024 Dec 14.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

August 6, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations