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Correlation of PET CT reesponse and post surgery and chemotherapy biopsy response in lung cancer patients

Not Applicable
Conditions
Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Registration Number
CTRI/2024/02/063096
Lead Sponsor
AIIMS New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Age 18-75 years Pathological diagnosis of NSCLC in Stage 2B or 3A . Being considered for neoadjuvant chemotherapy followed by surgery after discussion in MDT. Complete surgical removal should be deemed achievable including surgical fitness. ECOG (Eastern Cooperative Oncology Group) performance score 0to1. Adequate organ functions and marrow functions as described below

A. Serum creatinine less than equal to 1.5 mg or creatinine clearance more than equal 50 ml/min. B. Serum Bilirubin less than 1.5 UNL, ASTor ALT less than 3 UNL C. Hb more than 10.0 gmdl, Platelet counts more than 100 x10 9 L, absolute neutrophil count more than 1.5 X10 9L Able to understand the PIS (patient information sheet and give informed consent)

Exclusion Criteria

ECOG performance score more or equal to 2 .Harboring EGFR mutations, ALK and ROS1 rearrangements.Prior exposure to immune checkpoint inhibitors. Pre-existing autoimmune condition requiring systemic immunosuppression including steroids (more than 10 mg Prednisolone equivalent).
Acquired immunosuppression (HIV, systemic immunosuppression)
.Hematopoietic or organ transplant recipient. History of any other malignancy in past or synchronous malignancy.Pregnant and lactating mothers. Willing to afford or have access to immunotherapy outside study.Patients with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or compromise the patient’s ability to participate in this study.Uncontrolled diabetes mellitus with fasting plasma glucose persistently above 200 mgdl which could compromise the patient’s ability to undergo FDG PET-CT scan.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation of PERCIST based response on FDG PET-CT vis a vis RECIST based Response by CECT and their correlation with pathological responses. <br/ ><br>Timepoint: At Baseline and post completion of Neoadjuvant chemotherapy (9-12 weeks) <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Comparison of PERCIST criteria in patients receiving chemotherapy alone with its immunotherapy adapted iterations viz. imPERCIST and iPERCIST in patients receiving chemoimmunotherapy to predict pathological response.Timepoint: Baseline and after 3 cycles NACT
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