NCT03872362

Brief Summary

The investigators aim to investigate the utility of radiomics to differentiate malignant nodules from benign nodules and invasive adenocarcinoma from non-invasive adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
Last Updated

March 13, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

March 11, 2019

Last Update Submit

March 11, 2019

Conditions

Keywords

Lung cancerCTFrozen sectionsRadiomicsLung adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Malignant nodules classifier

    Model based on Radiomic that can differentiate malignant nodules from benign nodules.

    30 days

  • Invasive adenocarcinoma classifier

    Model based on Radiomic that can differentiate invasive adenocarcinoma from non-invasive adenocarcinoma.

    30 days

Study Arms (3)

Training dataset

No interventions

Diagnostic Test: radiomics

External validation1

No interventions

Diagnostic Test: radiomics

External validation2

No interventions

Diagnostic Test: radiomics

Interventions

radiomicsDIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

External validation1External validation2Training dataset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with pulmonary nodules in the collaborating institutes.

You may qualify if:

  • intraoperative frozen section diagnosis and final pathology diagnosis are available
  • preoperative standard non-enhanced CT is available
  • Pathologically confirmed

You may not qualify if:

  • with a previous history of radiation therapy, chemotherapy or biopsy
  • the time interval between the CT examination and surgery was more than two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116000, China

Location

Related Publications (1)

  • Wu G, Woodruff HC, Shen J, Refaee T, Sanduleanu S, Ibrahim A, Leijenaar RTH, Wang R, Xiong J, Bian J, Wu J, Lambin P. Diagnosis of Invasive Lung Adenocarcinoma Based on Chest CT Radiomic Features of Part-Solid Pulmonary Nodules: A Multicenter Study. Radiology. 2020 Nov;297(2):451-458. doi: 10.1148/radiol.2020192431. Epub 2020 Aug 25.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungLung DiseasesNeoplasmsAdenocarcinoma of Lung

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

July 11, 2018

Primary Completion

January 11, 2019

Study Completion

February 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-01

Locations