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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03960710
Other study ID # ASEPOL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date September 2019

Study information

Verified date May 2019
Source Hospices Civils de Lyon
Contact Bénédicte CAYOT
Phone 472110400
Email benedicte.cayot@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessing the volume of the liver before surgery, predicting the volume of liver remaining after surgery, detecting primary or secondary lesions in the liver parenchyma are common applications that require optimal detection of liver contours, and therefore liver segmentation.

Several manual and laborious, semi-automatic and even automatic techniques exist.

However, severe pathology deforming the contours of the liver (multi-metastatic livers...), the hepatic environment of similar density to the liver or lesions, the CT examination technique are all variables that make it difficult to detect the contours. Current techniques, even automatic ones, are limited in this type of case (not rare) and most often require readjustments that make automatisation lose its value.

All these criteria of segmentation difficulties are gathered in the livers of hepatorenal polycystosis, which therefore constitute an adapted study model for the development of an automatic segmentation tool.

To obtain an automatic segmentation of any lesional liver, by exceeding the criteria of difficulty considered, investigators have developed a convolutional neural network (artificial intelligence - deep learning) useful for clinical practice.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients = 18 years old

- Patients with hepato-renal polycystosis, with or without surgery

- Patients with at least one abdominal-pelvic CT scan without injection or with injection between January 1, 2016 and August 2018

- Patients with good quality and available images

Exclusion Criteria:

- Patients with no CT scan images available

- Patients with bad quality of CT scan images

Study Design


Intervention

Other:
Anonymized CT examinations
The anonymized CT examinations will be reviewed in Lyon, in the imaging department of Edouard Herriot Hospital, by an expert radiologist and an intern from the Lyon hospitals.
Training (1)
An initial training phase of the artificial intelligence network will be carried out : - Segmentation of the livers of a first part of the CT examination, by an intern of the Lyon hospitals
Training (2)
An initial training phase of the artificial intelligence network will be carried out : - Use of computer data to drive the artificial intelligence network.
Validation (1)
A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations : - Carried out by an intern at the Lyon hospitals
Validation (2)
A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations : - Carried out by the neural network

Locations

Country Name City State
France Service de radiologie - Pavillon B - Cellule Recherche imagerie, Hôpital Edouard Herriot (HCL) Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test of automatic segmentation by the convolutional neural network on these group and collection of data set Development of an automatic segmentation tool for highly dysmorphic polycystic livers as a prerequisite for segmentation of any type of multi-lesional livers that are difficult to segment, in order to facilitate lesion detection and volume measurement in clinical practice.
Randomisation of the patient into two data groups, one for training the other for Validating the convolutional neural network (artificial intelligence)
Manual segmentation of polycystic livers of the 1st training group and deep learning of convolutional neural network
Manual segmentation of polycystic livers of 2nd validation group
Test of automatic segmentation by the convolutional neural network on these group and collection of data set
At 4 months after randomization
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