Role of FDG PET, Immune and Hypoxic Marker in NSCLC

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02519062
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.

Detailed Description

This is a retrospective observation that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of 130 patients with NSCLC treated with surgery with radical intent at our center.

We will review FDG-PET acquired within 30 days prior to surgery and analyze its principal imaging characteristics with respect to hypoxic and immune-related markers at immunohistochemistry (IHC). These markers will be studied on tumor tissue obtained at surgery, used for diagnostic purposes and stored in paraffin.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosis of NSCLC (Stage I-III)
• FDG PET before surgery

Exclusion Criteria

• Absence of tumor specimen
• No clinical data
• FDG-PET can not be evaluated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of SUVmax (Maximal Standardized Uptake Value) in patients with non-small cell lung cancer undergoing surgery with hypoxia expression and tumor immune cell infiltration.	Baseline SUVmax up to 1 month before surgery.

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy