NCT03517306

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

April 19, 2018

Last Update Submit

April 2, 2019

Conditions

Lung Cancer

Keywords

lung cancer, FDG, PET/CT, radiomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Validation of a FDG PET/CT based radiomic score for survival

    Time Frame: 3 years

Study Arms (4)

Beijing

No interventions

Other: No Interventions

Ningxia

No interventions

Other: No Interventions

Wenzhou

No interventions

Other: No Interventions

Changzhou

No interventions

Other: No Interventions

Interventions

No InterventionsOTHER

No Interventions

BeijingChangzhouNingxiaWenzhou

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- The patient without follow-up information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 7, 2018

Study Start

May 1, 2018

Primary Completion

May 31, 2019

Study Completion

September 28, 2019

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

there is no plan to make individual participant data (IPD) available to other researchers.

Locations

CN(1)