Research for the Molecular Imaging of the PD-L1 Targeting Tracer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China
- Shunlian Zhou
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
WL12, labeled with PET radio-nuclide ( Ga-68 or F-18)will be used as a molecular imaging tracer for PET/CT scanning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019KT116/2019KT62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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