Lung CancerNCT03517306
PET/CT Based Radiomics for Lung Cancer (PERL)
An observational study of Lung Cancer, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The investigators investigate the utility of FDG PET/CT based radiomics in lung cancer, including diagnosis and prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 28 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The patient without follow-up information
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Jianhua Yan, PhD, 86-15824497979, jianhua.yan@gmail.com
Minfu Yang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- No Interventions
- Keywords
- lung cancer, FDG, PET/CT, radiomics
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| Beijing | No interventions Receives: Other: No Interventions | |
| Ningxia | No interventions Receives: Other: No Interventions | |
| Wenzhou | No interventions Receives: Other: No Interventions | |
| Changzhou | No interventions Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: 3 years
Secondary outcomes (1)
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)
Measured: Time Frame: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 May 2018
- Primary completion31 May 2019 (estimated)
- Study completion28 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, General Hospital of Ningxia Medical University, Soochow University, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Jianhua Yan, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517306
- Sponsor's protocol ID
- SAHoWMU-CR2018-05-223
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CTbased Radiomics for Lung Cancer (PERL): a Retrospective Multi-center Study
- ClinicalTrials.gov ID
- NCT03517306
- Acronym / sponsor ID
- SAHoWMU-CR2018-05-223
- Conditions
- Lung Cancer
- Keywords
- lung cancer, FDG, PET/CT, radiomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, General Hospital of Ningxia Medical University, Soochow University, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 28 Sep 2019 (estimated)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beijing | – | Other: No InterventionsNo interventions |
| Ningxia | – | Other: No InterventionsNo interventions |
| Wenzhou | – | Other: No InterventionsNo interventions |
| Changzhou | – | Other: No InterventionsNo interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient without follow-up information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsNo Interventions | Other | Beijing, Changzhou, Ningxia, Wenzhou |
Primary outcome
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.
1 secondary outcome
Validation of a FDG PET/CT based radiomic score for survival
Time frame: Time Frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a FDG PET/CT based radiomic score for survival (time frame: Time Frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.