PET/CT Based Radiomics for Lung Cancer (PERL)

• Conditions: Lung Cancer
• Interventions: Other: No Interventions

• Registration Number: NCT03517306
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

The investigators investigate the utility of FDG PET/CT based radiomics in lung cancer, including diagnosis and prognosis.

Detailed Description

Recent studies have shown that, in addition to inter-tumor heterogeneity, tumors often display startling intratumoral heterogeneity in various features including histology, gene expression, genotype, and metastatic and proliferative potential, which is often associated with adverse tumor biology. Unfortunately, it is difficult to assess intratumoral heterogeneity with random sampling or biopsy as this does not represent the full extent of phenotypic or genetic variation within a tumor. Given the limitations of current biopsy strategies, there is an important potential for medical imaging, which has the ability to capture intratumoral heterogeneity in a non-invasive way.

Borrowed from the concept in genomics and/or proteomics, radiomics was specifically proposed for medical or radiological images. It is a promising technique for improving diagnosis, staging, prognosis, treatment response prediction and potentially allowing personalization of cancer treatment. It is a process of extraction and analysis of high-dimensional image features from radiological images obtained with CT, MR or PET, which could be either qualitative or quantitative. The basic assumption of radiomics is that tumor biology could be captured by radiomic features .

The purpose of this study is to investigate the utility of FDG PET/CT based radiomics in lung cancer. Four PET/CT centers will be involved in this study, in which more than 1000 patients diagnosed as lung cancer will be retrospectively enrolled.

Study Timeline

• Study First Submitted: 2018-04-19
• Study Start: 2018-05-01
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Primary Completion: 2019-05-31
• Study Completion: 2019-09-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• All patients diagnosed as lung cancer patients who had a FDG PET/CT scan before treatment between 1 Jan, 2013 and 30 December, 2016 in the four collaborative hospitals.

Exclusion Criteria

• The patient without follow-up information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ningxia	No Interventions	No interventions
Changzhou	No Interventions	No interventions
Beijing	No Interventions	No interventions
Wenzhou	No Interventions	No interventions

Primary Outcome Measures

Name	Time	Method
Creation of a FDG PET/CT based radiomic score for survival	Time Frame: 3 years	Multiple quantitative radiomic features including SUV, metabolic volume, shape and texture will be measured from FDG PET/CT images. The all subjects will be randomly separated into a training and validation data. The multiple image features will be aggregated into a single combined radiomic score for survival with an appropriate machine learning method and the training data.

Secondary Outcome Measures

Name	Time	Method
Validation of a FDG PET/CT based radiomic score for survival	Time Frame: 3 years	The created radiomic score developed in the primary outcome will be evaluated with the validation data in terms of survival(progress-free or overall survival)

Trial Locations

Locations (1)

Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China