Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition

Philips Clinical & Medical Affairs Global265 enrolled

Overview

In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

265

Conditions

Pregnancy Related

Interventions

3D volume acquisitionsDEVICE

2 abdominal volumes 2 thigh volumes 2 head volumes

2D standard measurements and 3D volumes acquisitionsDEVICE

* 1 abdomen circumference measurement * 1 femur length measurement * 1 head circumference measurement * 1 bi-parietal diameter measurement * 1 abdominal volume * 1 thigh volume * 1 head volume

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * evolutive pregnancy with one fetus with a Gestational Age between 16 and 30 weeks * aged between 18 and 65 years. * social welfare benefit recipient * willing and able to provide informed consent Exclusion Criteria: * under 18 years old * multiple pregnancy * over 18 years old and mentioned in French law articles L.1126-6 et L-1126-8, * fetal malformation or suspected fetal malformation * technical conditions that do not allow for standard fetal biometry (abdominal wall, fetal position, BMI \> 25 kg/m2) * fetal biometry non indicated in the standard pregnancy follow-up * unwilling or unable to provide informed consent (e. g. physical, mental disability or linguistic factor that compromises patient information)

Locations (1)

CHRU de Nancy Brabois

Nancy, France

Outcomes

Primary Outcomes

Bi-parietal diameter in mm.

The bi-parietal diameter in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

Time frame: Day 1

Head circumference in mm

The Head circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

Time frame: Day 1

Abdominal circumference in mm

The Abdominal circumference in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported.

Time frame: Day 1

Femur length in mm

The Femur length in mm will be obtained with three methods: (1) fully automated 3D volume processing and caliper placement, (2) manual 3D volume processing and caliper placement, (3) manual selection of the 2D view plane and manual caliper placement on the screen of the ultrasound system (corresponding to standard of care measurements). The values obtained with the three methods and the differences between these values will be reported

Time frame: Day 1

Secondary Outcomes

Data from ClinicalTrials.gov

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Failure rate of the automated measurements

Time frame: Day 1

Exam and post-processing duration

Time frame: Day 1

Difference of scores of the 2D standard cephalic plane and cephalic plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The cephalic plane extracted from the 3D volume and the 2D standard cephalic plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

Time frame: Day 1

Difference of scores of the 2D standard abdominal plane and abdominal plane extracted from the 3D volume, based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The abdominal plane extracted from the 3D volume and the 2D standard abdominal plane will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

Time frame: Day 1

Difference of scores of the 2D standard femoral plane and femoral plane extracted from the 3D volume, based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The femoral plane extracted from the 3D volume and the 2D standard femoral plane will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and their difference will be reported.

Time frame: Day 1

Difference of scores of (i) the 2D standard cephalic plane and of (ii) the frames of a sequence of 2D images including the fetus head (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The 2D standard cephalic plane and the frames of a sequence of 2D images including the fetus head will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

Time frame: Day 1

Difference of scores of (i) the 2D standard abdominal plane and of (ii) the frames of a sequence of 2D images including the fetus abdomen (cine-loop), based on six criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The 2D standard abdominal plane and the frames of a sequence of 2D images including the fetus abdomen will be scored according to the six criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

Time frame: Day 1

Difference of scores of (i) the 2D standard femoral plane and of (ii) the frames of a sequence of 2D images including the fetus femur (cine-loop), based on four criteria listed in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40)

The 2D standard femoral plane and the frames of a sequence of 2D images including the fetus femur will be scored according to the four criteria described in (Salomon et al. Ultrasound Obstet Gynecol 2006; 27: 34-40). The scores and the score difference (standard view score - frame score) will be reported.

Time frame: Day 1

Title: Intraclass correlation coefficient of the bi-parietal diameter in mm (same operator)

The intraclass correlation coefficient of the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

Time frame: Day 1

Bland-Altman representation of the bi-parietal diameter in mm (same operator)

A Bland-Altman representation of the the bi-parietal diameter in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

Time frame: Day 1

Intraclass correlation coefficient of the bi-parietal diameter in mm (different operators)

The intraclass correlation coefficient of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

Time frame: Day 1

Bland-Altman representation of the bi-parietal diameter in mm (different operators)

A Bland-Altman representation of the bi-parietal diameter in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

Time frame: Day 1

Intraclass correlation coefficient of the head circumference in mm (same operator)

the intraclass correlation coefficient of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

Time frame: Day 1

Bland-Altman representation of the head circumference in mm (same operator)

A Bland-Altman representation of the head circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

Time frame: Day 1

Intraclass correlation coefficient of the head circumference in mm (different operators)

The intraclass correlation coefficient of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

Time frame: Day 1

Bland-Altman representation of the head circumference in mm (different operators)

A Bland-Altman representation of the head circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

Time frame: Day 1

Intraclass correlation coefficient of the abdominal circumference in mm (same operator)

The intraclass correlation coefficient of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

Time frame: Day 1

Bland-Altman representation of the abdominal circumference in mm (same operator)

A Bland-Altman representation of the abdominal circumference in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

Time frame: Day 1

Intraclass correlation coefficient of the abdominal circumference in mm (different operators)

The intraclass correlation coefficient of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

Time frame: Day 1

Bland-Altman representation of the abdominal circumference in mm (different operators)

A Bland-Altman representation of the abdominal circumference in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators built.

Time frame: Day 1

Intraclass correlation coefficient of the femoral length in mm (same operator)

The intraclass correlation coefficient of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be calculated.

Time frame: Day 1

Bland-Altman representation of the femoral length in mm (same operator)

A Bland-Altman representation of the femoral length in mm measured from two different 3D volumetric acquisitions of the same patient performed by the same operator will be built.

Time frame: Day 1

Title: Intraclass correlation coefficient of the femoral length in mm (different operators)

The intraclass correlation coefficient of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be calculated.

Time frame: Day 1

Bland-Altman representation of the femoral length in mm (different operators)

A Bland-Altman representation of the femoral length in mm measured from the 3D volumetric acquisitions of the same patient performed by two different operators will be built.

Time frame: Day 1