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

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Fudan University

Status

Enrolling

Conditions

Non-small Cell Lung Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06165874
KY2023-546

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

non-small cell lung cancer
Experimental group
Description:
Patients were recruited in the Department of Thoracic Surgery
Treatment:
Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging

Trial contacts and locations

1

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Central trial contact

Yihui Guan, MD

Data sourced from clinicaltrials.gov

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