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NCT Number: NCT06623487

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoadjuvant Immunotherapy Neoplasms Neoplasms by Site PET / CT Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

yi xiang

CONTACT

[email protected]

13816967846

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Predictive performance 1

    Time frame: up to the end of surgery

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

Secondary outcomes

  1. Predictive performance 2

    Time frame: 3 years

    Assessing the predictive value of 68Ga-grazytracer PET for adjuvant immunotherapy efficacy after surgery, as measured by disease-free survival

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer: a Prospective, Observationa Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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