Imaging method for diagnosing PD-L1-expressing lung cancer

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

This study is testing a new imaging method to see if it can help find lung cancer in patients with specific tumor characteristics who haven't had surgery yet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06165874 on ClinicalTrials.gov

What this trial studies

This study aims to establish and optimize the imaging method using [68Ga]Ga-NOTA-RW102 for patients with non-small cell lung cancer. It evaluates the physiological and pathological distribution characteristics of this imaging agent to determine its diagnostic efficacy. Patients with PD-L1-positive tumors will undergo PET imaging to assess the effectiveness of this novel approach in identifying lung cancer. The study focuses on patients who have not undergone surgery and have specific CT findings.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 65 with PD-L1-positive non-small cell lung cancer and specific CT findings.

Not a fit: Patients with severe hepatic or renal insufficiency or those who have received targeted therapy prior to the imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging method could improve the accuracy of diagnosing PD-L1-expressing lung cancer, leading to better-targeted therapies.

How similar studies have performed: While there have been studies on PET imaging for lung cancer, the specific use of [68Ga]Ga-NOTA-RW102 for PD-L1 expression is a novel approach.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Fang Xie, PhD — Huashan Hospital
• Study coordinator: Yihui Guan, MD

Conditions: Non-small Cell Lung Cancer, non-small cell lung cancer, Positron-Emission Tomography