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

December 11, 2023 updated by: YiHui Guan, Huashan Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 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
90mins from time of injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2023

Primary Completion (Actual)

October 13, 2023

Study Completion (Estimated)

January 14, 2024

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-546

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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