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

NCT06165874 | Unknown

• 1 other identifier: KY2023-546
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

non-small cell lung cancer

EXPERIMENTAL

Patients were recruited in the Department of Thoracic Surgery

Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging

Interventions

[68Ga]Ga-NOTA-RW102 PET Imaging RADIATION

Intravenous injection of 1.8 MBq\[0.05MCi\]/kg of \[68Ga\]Ga-NOTA-RW102 in a single dose.

non-small cell lung cancer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

Related Publications (1)

• Zhang Y, Cao M, Wu Y, Malih S, Xu D, Yang E, Younis MH, Lin W, Zhao H, Wang C, Liu Q, Engle JW, Rasaee MJ, Guan Y, Huang G, Liu J, Cai W, Xie F, Wei W. Preclinical development of novel PD-L1 tracers and first-in-human study of [68Ga]Ga-NOTA-RW102 in patients with lung cancers. J Immunother Cancer. 2024 Apr 5;12(4):e008794. doi: 10.1136/jitc-2024-008794.

  PMID: 38580333 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

+8613764308300; guanyihui@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 12, 2023
• Study Start: March 12, 2023
• Primary Completion: October 13, 2023
• Study Completion: January 14, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CN (1)