[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer

Study Overview
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Brief Summary
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The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RW102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer

Official Title
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[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with PD-L1-positive non-small cell lung cancer Age between 18 and 65 years old, gender is not limited. Patients with CT findings that can be occupied on the lung with a diameter greater than 1cm or more who have not undergone surgery. Lung cancer patients with a clinical diagnosis of positive PD-L1 expression; Written informed consent must be signed by the subject or his/her legal guardian or caregiver. Willingness and ability to cooperate with all programs of this study. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Severe hepatic and renal insufficiency; Targeted therapy prior to radiotherapy or PET/CT scan. PD-L1 expression in existing lesions was assessed by immunohistochemistry using antibody clone 22C3. Renal function: serum creatinine less than or equal to the upper limit of the normal range; Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-small cell lung cancer<br>Patients were recruited in the Department of Thoracic Surgery | Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging<br>* Intravenous injection of 1.8 MBq[0.05MCi]/kg of [68Ga]Ga-NOTA-RW102 in a single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation and comparison of [68Ga]Ga-NOTA-RW102 radioactivity concentrations in focal and non-focal tissues | Assessment of the efficacy of [68Ga]Ga-NOTA-RW102 in the diagnosis and differential diagnosis of non-small cell lung cancer | 90mins from time of injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, Positron-Emission Tomography