Fully Automated Pipeline for the Detection and Segmentation of Non-Small Cell Lung Cancer (NSCLC) on CT Images

Sponsor
Maastricht University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04164186
Collaborator
Centre Hospitalier Universitaire de Liege (Other), University Hospital RWTH Aachen University, Aachen, Germany. (Other), Affiliated Zhongshan Hospital of Dalian University, 6 Jiefang street, Dalian 116001, China (Other), University of California, San Francisco (Other)
1,043
1
19.7
52.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Automatic detection and segmentation of NSCLC tumors

Detailed Description

In this study, we aim to develop and test 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. We will assess the level of agreement between a group of radiologists, performing manual versus semi-automatic tumour segmentation. To do so, we will provide radiologists with two sets of CT scans. The first set will be segmented manually; the second one will be segmented using the automated software program.

Subsequently, we will use the inter- and intra-observer variance from the clinical study in a simulation or modeling study. We also compare the time needed and the consistency in segmentations by the software to medical doctors performance.

Reliability and Agreement study:

Primary tumours of 25 lung cancer patients will be delineated by 6 segmentation experts.

  1. Assess agreement between automatic segmentation and radiologists' segmentation The primary tumours of 25 patients will be manually segmented by the radiologists and automatically by the the tool. The time needed to perform this task and the reproducibility of the segmentation will be recorded. The degree of overlap between the ROs and the automatic contour will be assessed pairwise using the Dice coefficient.

  2. Delination of tumours by the experts, assisted by the software tool For another 25 patients, the experts will be provided with an automatic delineation, performed by the tool. They have the possibility to adjust and validate it. The time needed will be recorded. The difference between the mean overlap fraction in the first situation (manual delineation of experts) and the second situation (delineation of experts+ software tool) will be assessed, using a multi-observer Dice coefficient.

  3. Assessment of intra-observer variance The experts will repeat the segmentation of the lung tumours after 2 weeks. They will repeat the manual segmentation (n=25) and the semi-automatic segmentation (n=25). This will make it possible to assess the intra-observer variance in both situations.

  4. Qualitative assessment of the experts' preferences using an in-house developed visualization toolbox.

Study Design

Study Type:
Observational
Actual Enrollment :
1043 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Fully Automated Pipeline for the Detection and Segmentation of Non-Small Cell Lung Cancer (NSCLC) on CT Images: Quantitative and Qualitative Evaluation
Actual Study Start Date :
Mar 10, 2019
Actual Primary Completion Date :
Nov 7, 2019
Anticipated Study Completion Date :
Oct 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Detection of NSCLC on CT scans [November, 2019]

    Automatic detection of NSCLC tumors

  2. Segmentation of NSCLC scans [November, 2019]

    Automatic segmentation of NSCLC tumors

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Availability of CT scans

  • Availability of definite diagnosis

Exclusion Criteria:
  • Lack of segmentations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Maastricht Limburg Netherlands 6229ER

Sponsors and Collaborators

  • Maastricht University
  • Centre Hospitalier Universitaire de Liege
  • University Hospital RWTH Aachen University, Aachen, Germany.
  • Affiliated Zhongshan Hospital of Dalian University, 6 Jiefang street, Dalian 116001, China
  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University
ClinicalTrials.gov Identifier:
NCT04164186
Other Study ID Numbers:
  • ALSP
First Posted:
Nov 15, 2019
Last Update Posted:
Apr 6, 2020
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2020