- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03517306
PET/CT Based Radiomics for Lung Cancer (PERL)
PET/CTbased Radiomics for Lung Cancer (PERL): a Retrospective Multi-center Study
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Recruiting
- Second Affiliated Hospital of Wenzhou Medical University
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Contact:
- Jianhua Yan, PhD
- Phone Number: 86-15824497979
- Email: jianhua.yan@gmail.com
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Principal Investigator:
- Minfu Yang, MD
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Principal Investigator:
- Juan Li, MD
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Principal Investigator:
- Xiangwu Zheng, MD
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Principal Investigator:
- Yuetao Wang, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Beijing
No interventions
|
No Interventions
|
Ningxia
No interventions
|
No Interventions
|
Wenzhou
No interventions
|
No Interventions
|
Changzhou
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
Time Frame: 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.
|
Time Frame: 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of a FDG PET/CT based radiomic score for survival
Time Frame: 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)
|
Time Frame: 3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAHoWMU-CR2018-05-223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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