NCT04000620

Brief Summary

Lung cancer diagnosis and staging are two fundamental and critical issue in clinical lung cancer management and therapeutic decision-making. Invasive procedures for pathologic analysis are gold standard for diagnosis and staging, however, invasive procedures related-complications are inevitable. Noninvasive medical imaging is a powerful tool, however there is almost no room for improvement just according to the experience of radiologist and clinician. The researchers will investigate the role of computer based deep learning of medical imaging in the diagnosis of lesion of lung, lymph node and other sites suspected with metastasis.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

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

May 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

3.7 years

First QC Date

June 24, 2019

Last Update Submit

November 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • pathologic result revealed cancer cell involvement in lesion

    1 month after the pathologic test

Study Arms (2)

cancer cell involvement predicted by deep learning

the participants with lesions of lung, lymph node or other sites predicted as positive for cancer cell involvement by imaging based deep learning.

Procedure: surgeryProcedure: punture

no cancer cell involvement predicted by deep learning

the participants with lesions of lung, lymph node or other sites predicted as negative for cancer cell involvement by imaging based deep learning.

Procedure: surgeryProcedure: punture

Interventions

surgeryPROCEDURE

treatment intent surgery

cancer cell involvement predicted by deep learningno cancer cell involvement predicted by deep learning
punturePROCEDURE

diagnostic punture

cancer cell involvement predicted by deep learningno cancer cell involvement predicted by deep learning

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients with PET/CT or CT examination before any cancer-specific treatment

You may qualify if:

  • Pathological diagnosis of lung cancer
  • PET/CT or CT examination before any cancer-specific treatment

You may not qualify if:

  • A history of other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Zhilei Lv, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 27, 2019

Study Start

May 1, 2018

Primary Completion

December 30, 2021

Study Completion

May 1, 2024

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations