Lung Nodule Imaging Biobank for Radiomics and AI Research

NCT ID: NCT04270799

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-08-31

Brief Summary

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This study will collect retrospective CT scan images and clinical data from participants with incidental lung nodules seen in hospitals across London. The investigators will research whether machine learning can be used to predict which participants will develop lung cancer, to improve early diagnosis.

Detailed Description

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Conditions

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Lung Cancer Pulmonary Nodule, Multiple Pulmonary Nodule, Solitary Lung Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lung Nodules

A cohort of 1000 patients with incidental lung nodules will be identified using clinical records at participating NHS sites.

Link-anonymised CT scan images and data will be stored using a central database for radiomics and artificial intelligence research, to predict the risk of malignancy.

Machine Learning Classification

Intervention Type DIAGNOSTIC_TEST

Patient's scans will be used as input into in-house software to extract multiple radiomics features. These features will be used to develop a risk-signature which can predict malignancy risk. Patient scans will also be used as input into deep learning/convolutional neural network models to perform automated imaging classification.

Interventions

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Machine Learning Classification

Patient's scans will be used as input into in-house software to extract multiple radiomics features. These features will be used to develop a risk-signature which can predict malignancy risk. Patient scans will also be used as input into deep learning/convolutional neural network models to perform automated imaging classification.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Baseline CT thorax imaging reported as having pulmonary nodule(s) between 5 and 30mm in the last 10 years.
* Ground truth known (either scan data showing stability for 2 years (based on diameter) or one year (based on volumetry), complete resolution, or biopsy-proven malignancy.
* Slice thickness \< 2.5mm.

Exclusion Criteria

* • Absence of at least one technically adequate CT thorax imaging series (defined by visual inspection of presence of imaging data of the thorax in the DICOM record).

* Slice thickness \> 2.5mm.
* Imaging \> 10 years old.
* Ground truth unknown.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RM Partners West London Cancer Alliance

UNKNOWN

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Lewisham and Greenwich NHS Trust

OTHER_GOV

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Epsom and St Helier University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

UCLH Biomedical Research Centre

UNKNOWN

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lee, MBBS PhD

Role: STUDY_CHAIR

The Royal Marsden Hospital

Locations

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Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status RECRUITING

Lewisham and Greenwich NHS Trust

London, Greater London, United Kingdom

Site Status RECRUITING

Epsom and St Helier's Hospitals NHS Trust

Carshalton, Surrey, United Kingdom

Site Status NOT_YET_RECRUITING

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

The Royal Brompton NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Richard Lee, MBBS PhD

Role: CONTACT

020 7352 8171

Facility Contacts

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Benjamin Hunter

Role: primary

Dr Shafick Gareeboo

Role: primary

Jonathon Ratoff

Role: primary

Dr Neal Navani

Role: primary

Anand Deveraj

Role: primary

020 7352 8121

Other Identifiers

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CCR5215

Identifier Type: -

Identifier Source: org_study_id

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