The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung; PET / CT; Neoadjuvant Immunotherapy

• Registration Number: NCT06623487
• Lead Sponsor: Ruijin Hospital

Brief Summary

Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-19
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-29
• Last Update Submitted: 2024-09-29
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2026-06-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;
2. Fully-informed written consent obtained from patients;
3. Patient ability to comply with protocol requirements;
4. Age 18-75 years;
5. Life expectancy of at least 6 months.

Exclusion Criteria

1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
2. Intestinal perforation, complete intestinal obstruction;
3. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive performance 1	up to the end of surgery	Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.

Secondary Outcome Measures

Name	Time	Method
Predictive performance 2	3 years	Assessing the predictive value of 68Ga-grazytracer PET for adjuvant immunotherapy efficacy after surgery, as measured by disease-free survival

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China