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PD-L1 Targeting Molecular Imaging of Gastrointestinal Tumors

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. Identifier: NCT04629326
Recruitment Status : Not yet recruiting
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Information provided by (Responsible Party):
Hua Zhu, Beijing Cancer Hospital

Brief Summary:
The objective of the study is to constrcut a noninvasive approach 68Ga-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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tumors Other: 68Ga-WL12 PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PD-L1 Targeting Molecular Imaging of Gastrointestinal Tumors
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 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 68Ga-WL12 PET/CT scans
Other: 68Ga-WL12 PET/CT
WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning

Primary Outcome Measures :
  1. Standardized uptake value(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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT04629326

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Contact: Hua Zhu 010-88196495

Sponsors and Collaborators
Beijing Cancer Hospital
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Responsible Party: Hua Zhu, Associate Professor, Beijing Cancer Hospital Identifier: NCT04629326    
Other Study ID Numbers: WL12-GI
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases