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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04629326
Other study ID # WL12-Tumor
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 20, 2021
Est. completion date November 2024

Study information

Verified date January 2024
Source Peking University Cancer Hospital & Institute
Contact Hua Zhu
Phone 010-88196495
Email zhuhuabch@pku.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
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