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

NCT ID: NCT06165874

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-12

Study Completion Date

2024-01-14

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

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Keywords

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non-small cell lung cancer Positron-Emission Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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non-small cell lung cancer

Patients were recruited in the Department of Thoracic Surgery

Group Type EXPERIMENTAL

[68Ga]Ga-NOTA-RW102 PET Imaging

Intervention Type RADIATION

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

Interventions

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[68Ga]Ga-NOTA-RW102 PET Imaging

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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YiHui Guan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

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Huashan Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yihui Guan, MD

Role: CONTACT

Phone: +8613764308300

Email: [email protected]

Facility Contacts

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Yihui Guan, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38580333 (View on PubMed)

Other Identifiers

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KY2023-546

Identifier Type: -

Identifier Source: org_study_id