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

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging

• Registration Number: NCT06165874
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-12
• Primary Completion: 2023-10-13
• Study First Submitted: 2023-11-19
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Study Completion: 2024-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with PD-L1-positive non-small cell lung cancer

  1. Age between 18 and 65 years old, gender is not limited.
  2. Patients with CT findings that can be occupied on the lung with a diameter greater than 1cm or more who have not undergone surgery.
  3. Lung cancer patients with a clinical diagnosis of positive PD-L1 expression;
  4. Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
  5. 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:

  1. Severe hepatic and renal insufficiency;
  2. 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;
  3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
  4. History of serious surgery in the last month.
  5. Those who have participated in other clinical trials during the same period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-small cell lung cancer	[68Ga]Ga-NOTA-RW102 PET Imaging	Patients were recruited in the Department of Thoracic Surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China