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Research for the Molecular Imaging of the PD-L1 Targeting Tracer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304066
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Hua Zhu, Peking University Cancer Hospital & Institute

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Lung Cancer Other: 18F-WL12 PET or 68Ga-WL12 PET Not Applicable

Detailed Description:

In many clinical trials, Anti-PD-1/PD-L1 mAbs have achieved great success than expected in a variety of refractory and recurrent tumor patients. The latest research shows that it is not all cancer patients would respond to Anti-PD-1/PD-L1 mAbs. At present, immunohistochemistry (IHC) is still a common method to screen patients that will benefit from this therapy by detecting the expression level of PD-1 and PD-L1. However, the results of IHC were not very exact because of limitations of IHC such as the heterogeneity of expression, the influence of host cell PD-L1 expression and the changes in the course of the disease. Moreover, the tumor tissue used in IHC must obtained through the invasive method. It is difficult to dynamically monitor the expression level of PD-1 / PD-L1 during the treatment. Immuno-PET molecular imaging By radiolabeling Anti-PD-1/PD-L1 mAbs with radionuclides can be used to noninvasive assessment of biodistribution of monoclonal antibodies and provide a new strategy for patient screening.

In this study, 18F-WL12 or 68Ga-WL12 PET / CT imaging will be performed in patients with solid tumors to access the potential of 18F-WL12 or 68Ga-WL12PET / CT to screen patients who can benefit from JS001 treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Research for the Molecular Imaging of the PD-L1 Targeting Tracer
Actual Study Start Date : March 17, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging cohort
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
WL12, labeled with PET radio-nuclide ( Ga-68 or F-18)will be used as a molecular imaging tracer for PET/CT scanning




Primary Outcome Measures :
  1. SUV [ Time Frame: 2 years ]
    The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value(SUV)on PET/CT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304066


Contacts
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Contact: Hua Zhu 010-88196495 zhuhuabch@pku.edu.cn

Locations
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China
Shunlian Zhou Recruiting
Beijing, China
Contact: Shunlian Zhou    010-88196391    zhoushunlian@163.com   
Sponsors and Collaborators
Peking University Cancer Hospital & Institute
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Responsible Party: Hua Zhu, Associate Professor, Peking University Cancer Hospital & Institute
ClinicalTrials.gov Identifier: NCT04304066    
Other Study ID Numbers: 2019KT116/2019KT62
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No