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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165874
• Other study ID #: KY2023-546
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2023
• Est. completion date: January 14, 2024

Study information

• Verified date: December 2023
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: +8613764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 14, 2024
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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