PET/CT Based Radiomics for Lung Cancer (PERL)

PET/CTbased Radiomics for Lung Cancer (PERL): a Retrospective Multi-center Study

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

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Other: No Interventions

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Jianhua Yan, PhD; Phone Number: 86-15824497979; Email: jianhua.yan@gmail.com
      • Principal Investigator: Minfu Yang, MD
      • Principal Investigator: Juan Li, MD
      • Principal Investigator: Xiangwu Zheng, MD
      • Principal Investigator: Yuetao Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beijing; No interventions	Other: No Interventions; No Interventions
Ningxia; No interventions	Other: No Interventions; No Interventions
Wenzhou; No interventions	Other: No Interventions; No Interventions
Changzhou; No interventions	Other: No Interventions; No Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a FDG PET/CT based radiomic score for survival	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.	Time Frame: 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a FDG PET/CT based radiomic score for survival	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)	Time Frame: 3 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborators: Beijing Chao Yang Hospital; General Hospital of Ningxia Medical University; First Affiliated Hospital of Wenzhou Medical University; Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): September 28, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: lung cancer, FDG, PET/CT, radiomics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SAHoWMU-CR2018-05-223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No