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

NCT06623487 | Recruiting DMC

• 1 other identifier: KY2024-233
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Predictive performance 1

  Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.

  up to the end of surgery

Secondary Outcomes (1)

• Predictive performance 2

  3 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.

You may qualify if:

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

You may not qualify if:

• 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;
• Intestinal perforation, complete intestinal obstruction;
• Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
• Pregnant women and women who are potentially pregnant, as well as nursing mothers;
• Patients with poor compliance.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 2, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

CN (1)