PET/CT Based Radiomics for Lung Cancer (PERL)

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03517306
• Other study ID #: SAHoWMU-CR2018-05-223
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: September 28, 2019

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 28, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No Interventions
No Interventions

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (5)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University	Beijing Chao Yang Hospital, First Affiliated Hospital of Wenzhou Medical University, General Hospital of Ningxia Medical University, Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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