NCT04164186

Brief Summary

Accurate segmentation of lung tumor is essential for treatment planning, as well as for monitoring response to therapy. It is well-known that segmentation of the lung tumour by different radiologists gives different results (inter-observer variance). Moreover, if the same radiologist is asked to repeat the segmentation after several weeks, these two segmentations are not identical (intra-observer variance). In this study we aim to develop an automated pipeline that can produce swift, accurate and reproducible lung tumor segmentations.

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
1,043

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

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

Study Start

First participant enrolled

March 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

April 6, 2020

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 12, 2019

Last Update Submit

April 3, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Detection of NSCLC on CT scans

    Automatic detection of NSCLC tumors

    November, 2019

  • Segmentation of NSCLC scans

    Automatic segmentation of NSCLC tumors

    November, 2019

Interventions

an automated deep learning detection and segmentation software for non-small cell lung cancer (NSCLC) that can automatically detect and segment tumors on CT scans and thus reduce the human variation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CT scans of 1043 patients diagnosed with NSCLC at one of the 8 centers (Netherlands, USA, China, Belgium) were collected retrospectively. All patients had a biopsy to confirm the diagnosis

You may qualify if:

  • Availability of CT scans
  • Availability of definite diagnosis

You may not qualify if:

  • Lack of segmentations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 15, 2019

Study Start

March 10, 2019

Primary Completion

November 7, 2019

Study Completion

October 31, 2020

Last Updated

April 6, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Currently, there is no plan to make it public

Available IPD Datasets

Individual Participant Data Set (NSCLC Radiomics Interobserver)Access
Individual Participant Data Set (NSCLC Radiomics)Access
Individual Participant Data Set (NSCLC Radiogenomics)Access

Locations