The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Predictive performance 1
Sensitivity and specificity of 68Ga-grazytracer PET in predicting pathological response.
Time frame
up to the end of surgerySecondary outcomes
1
Predictive performance 2
Assessing the predictive value of 68Ga-grazytracer PET for adjuvant immunotherapy efficacy after surgery, as measured by disease-free survival
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov