Back to resultsPD-L1 Targeting Molecular Imaging of Solid Tumors
Primary Purpose
Gastrointestinal Tumors
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-WL12 PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Tumors
Eligibility Criteria
Inclusion Criteria:
- 1. Aged >18 years old; ECOG 0 or 1;
- 2. Patients with Gastrointestinal 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.
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging cohort
Arm Description
All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans
Outcomes
Primary Outcome Measures
Standardized uptake value（SUV）
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
Secondary Outcome Measures
Full Information
NCT ID
NCT04629326
First Posted
November 10, 2020
Last Updated
July 18, 2022
Sponsor
Peking University Cancer Hospital & Institute
1. Study Identification
Unique Protocol Identification Number
NCT04629326
Brief Title
PD-L1 Targeting Molecular Imaging of Solid Tumors
Official Title
PD-L1 Targeting Molecular Imaging of Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of the study is to constrcut a noninvasive approach WL12 PET/CT to detect the PD-L1 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from anti-PD-1/L1 treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imaging cohort
Arm Type
Experimental
Arm Description
All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-WL12 PET/CT scans
Intervention Type
Other
Intervention Name(s)
68Ga-WL12 PET/CT
Intervention Description
WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning
Primary Outcome Measure Information:
Title
Standardized uptake value（SUV）
Description
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value（SUV）on PET/CT
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Aged >18 years old; ECOG 0 or 1;
2. Patients with Gastrointestinal 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Zhu
Phone
010-88196495
Email
zhuhuabch@pku.edu.cn
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhu
Phone
+861088196495
Email
zhuhuananjing@163.com
12. IPD Sharing Statement
Learn more about this trial
PD-L1 Targeting Molecular Imaging of Solid Tumors
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