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Assessment of fetal lung maturity
by ultrasound texture analysis
fetal i+D - Fetal Medicine Research Center
BCNatal – Centre de Medicina Maternofetal i Neonatologia de Barcelona
Hospital Clínic - Hospital Sant Joan de Déu
Universitat de Barcelona
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
NEONATAL RESPIRATORY MORBIDITY
EUROPE AND EEUU
2-3% (200-300 K) / year
≥
5
6
7
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL
INDICACIÓN DE FINALIZACIÓN
(o información sobre madurez pulmonar fetal)
<"35.0"sem"
≥"35.0"'"<39.0!!sem!
Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.!
Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).!
"
Ha"recibido"corticoides"
y"quantusFLM®"disponible"
!(si!no!disponible,!administrar!corticoides!de!
acuerdo!con!recomendaciones)!!
N
N
NO"ha"recibido"corticoides:!!corticoides.!
!
"
Si!inducción!del!parto!y!<!37.0!sem!o!!
Si!CS!electiva!y!<!39.0!sem!
A!partir!del!día!siguiente!a!la!!2ª!dosis:!
MPF
MPF
BAJO!riesgo!de!
!morbilidad!respiratoria!neonatal*!
Programar!
finalización
BAJO!riesgo!de!
!morbilidad!respiratoria!neonatal*!
ALTO!riesgo!de!
morbilidad!respiratoria!neonatal*
Según!indicación!y!EG,!considerar:!
N!demorar!!3N7!días!la!finalización!y/o!!
N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!!
N!reevaluar!quantusFLM®!en!1!sem!o!
N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología!
!
*Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea!
transitoria!neonatal
Programar!
finalización
(1)"Ejemplos"de"situaciones"potenciales":"
NHipertensión!crónica!o!diabetes!de!difícil!control.!
NBalance!hídrico!positive!con!discomfort!severo!materno.!
NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.!
NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.!
NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.!
PROTOCOLS DE MEDICINA FETAL I PERINATAL
4/4
9
36.0w, 38y, IVF
Chronic HT + poorly controlled diabetes. Edema with maternal discomfort
No absolute medical indication.
¿RISK NRM?
BASELINE: AT 36W = 6%
INDIVIDUALIZED: TEST LUNG MATURITY
(*IF CORTICOIDS REDUCE
40% RISK)
LOW RISK
=2%
HIGH RISK
=36%
Delivery.
Risk probably higher than waiting.
Wait 1w and repeat test
Neonatal respiratory morbidity
Clinical use of NRM assessment
Ultrasound Texture Analysis
www.medicinafetalbarcelona.org/
TRANSMURAL
Fetal and Perinatal Medicine Research Group
BIOTECH
Background
Is it possible to use ultrasound to test fetal lung maturity?
Grannum, P.A., R.L. Berkowitz, and J.C. Hobbins, The ultrasonic changes in the maturing placenta and their relation to fetal pulmonic
maturity. Am J Obstet Gynecol, 1979.
Fried, A.M., et al., Echogenicity of fetal lung: relation to fetal age and maturity. AJR Am J Roentgenol, 1985
Harman, C.R., et al., The correlation of ultrasonic placental grading and fetal pulmonary maturation in five hundred sixty-three pregnancies.
Am J Obstet Gynecol, 1982.
Golde, S.H., M.P. Tahilramaney, and L.D. Platt, Use of ultrasound to predict fetal lung maturity in 247 consecutive elective cesarean
deliveries. J Reprod Med, 1984.
Zilianti, M. and S. Fernandez, Correlation of ultrasonic images of fetal intestine with gestational age and fetal maturity. Obstet Gynecol, 1983.
Feingold, M., et al., Fetal lung to liver reflectivity ratio and lung maturity. J Clin Ultrasound, 1987.
www.medicinafetalbarcelona.org
TRANSMURAL
Fetal and Perinatal Medicine Research Group
BIOTECH
Background
Is it possible to use ultrasound to test fetal lung maturity?
Quantitative ultrasound analysis
Chen, D.R., et al., Diagnosis of breast tumors with sonographic texture analysis using
wavelet transform and neural networks. Ultrasound Med Biol, 2002.
Wan, C., et al., Evaluation of breast lesions by contrast enhanced ultrasound:
Qualitative and quantitative analysis. Eur J Radiol. 2011.
Hartman, P.C., et al., Variability of quantitative echographic parameters of the liver:
intra- and interindividual spread, temporal- and age-related effects. Ultrasound Med
Biol, 1991.
Kadah, Y.M., et al., Classification algorithms for quantitative tissue characterization of
diffuse liver disease from ultrasound images. IEEE Trans Med Imaging, 1996.
Tekesin, I., et al., Assessment of fetal lung development by quantitative ultrasonic
tissue characterization: a methodical study. Prenat Diagn, 2004.
Maeda, K.S., M., Fetal lung immaturity assessment with ultrasonic tissue
characterization：GLHW. 26th The Fetus as a Patient, San Diego, 16:40, April 27
2010.
www.medicinafetalbarcelona.org
Design : STEP 1
Describe fetal lung texture along gestation
900 pregnant women from 16.0 to 42.0 weeks
Inclusion criteria: Low risk pregnant women
Exclusion criteria: Fetal malformations, Multiple gestation
www.medicinafetalbarcelona.org/
Design : STEP 2
Correlate fetal lung texture with the FLM-TDx II
ü To perform 2D US image the same day (± 12 h) of AF collection
ü Graphical User Interface (GUI) delineation
ü FLM results obtained by amniocentesis: mature/immature
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Design : STEP 2
Correlate fetal lung texture (AQUA) with the FLM-TDx II
n 69
(range 24.6 to 40.2 w)
• Mature: n= 22
• Immature: n = 47
Sensitivity of 86%, Specificity of 98%, Accuracy of 90%
Performance of an automatic quantitative ultrasound analysis (AQUA) texture extractor to predict fetal lung maturity assessed by TDx-FLM in
amniotic fluid.
Palacio M, Cobo T, Martínez M, Rattá G, Elías N, Bonet E, Amat I, Gratacós E.
Award of Research Excellence. Oral presentation www.medicinafetalbarcelona.org/
SMFM 2012, Dallas.
Design : STEP 1
900 images
957 images
From June 2010 to December 2010
Do not use direct grey level
Do not use tissue reference
Various settings admitted
Not strictly influenced by the ROI acquired
Analysis off-line
www.medicinafetalbarcelona.org/
R Pearson correlation = 0.98
•
•
•
•
N=144
Singleton pregnancies
29.0 - 38.6 w
Axial thoracic section
Non Invasive Assessment of the
risk of Neonatal Respiratory morbidity
www.quantusFLM.com
Patient & Provider Information
PATIENT NAME:
CLINIC NAME:
Name Surname
Complete Center Name
PATIENT ID:
REFERRING/ORDERING CLINICIAN:
NHC12345678
Sabino Arana 38 1 1
08028 Barcelona, Spain
CIF: B 65084675
Clinician Name Surname
QUANTUSFLM ID:
REPORT DATE:
(dd/mm/yyyy)
btech 123
01/01/2000
Test Result NEONATAL RESPIRATORY MORBIDITY
Sample Information
QUANTUSFLM ID:
btech 123
RESULT:
LOW RISK
Neonatal Respiratory Morbidity (*):
Theoretical risk for ## weeks of gestation:
##.# %
quantusFLM risk:
•
•
##.# %
RECOMMENDATION:
(dd/mm/yyyy)
GESTATIONAL AGE:
## weeks # days
US ACQUISITION DATE:
(dd/mm/yyyy)
01/01/2000
REQUEST DATE:
(dd/mm/yyyy hh:mm)
01/01/2000 00:00
Imatge Firma
90%
NEONATAL RESPIRATORY MORBIDITY RISK
80%
70%
60%
50%
40%
70%
60%
50%
40%
HIGH
RISK
30%
20%
10%
20%
10%
0%
LOW
RISK
Theoretical Risk*
quantusFLM Risk
100%
90%
Respiratory Distress Syndrome
Transient tachypnea of newborn
Technical Responsible:
Elisenda Bonet i Carné, MSc
Graphic Test Result
100%
Review results with patient
AUTHORIZED SIGNER/S:
80%
TEST DESCRIPTION
quantusFLM™ offers an automatic assessment of neonatal respiratory morbidity risk using an ultrasound
image of the lateral axial transverse section of the fetal thorax at the level of the 4 chamber section of the
fetal heart. quantusFLM™ is based on quantitative ultrasound texture analysis to extract information from
ultrasound images and a classifier which uses the extracted information to assess the risk. Test result
depends on the delineation of the fetal lung and incorporated the gestational age. Neonatal respiratory
morbidity is defined as respiratory distress syndrome or transient tachypnea of the newborn.
Test has been validated in singleton pregnancies from 28.0 to 39.0 weeks of gestation. Test are neither
intended nor validated for use in pregnancies with fetal structural abnormalities, chromosomal
abnormalities, multiple pregnancies or maternal BMI>35. This result should not be considered as a final
indication but as additional information to be considered in evaluation of the patient.
30%
0%
CLINICAL DATA SPECIFICATIONS
Accuracy
87% (95% CI:82 90%)
Sensitivity
91% (95% CI:77 98%)
Specificity
86% (95% CI:82 90%)
Positive Predictive Value
47% (95% CI:35 59%)
Negative Predictive Value
98% (95% CI:96 99%)
REFERENCE: Quantitative ultrasound texture analysis of fetal lung to predict neonatal respiratory morbidity. UOG (2014)
quantusFLM Test is intended for clinical use and should not be regarded as investigational or for research. Present result has been obtained using quantusFLM X.X.
Under the previous of Law 15/1999 normative, we inform you that your data will be included in a data base owned by TransmuralBiotech, S.L. for its clinical treatment. You may exercise the rights of access,
rectification, cancellation and opposition contacting us at [email protected].
(*) RDS: Respiratory symptoms (eg, grunCng, flaring, tachypnea, retracCons), O2 requirement + chest Rx + NICU admission TT: chest Rx impression + clinical diagnosis by clinician in charge.
JAMA 2010
www.medicinafetalbarcelona.org/
vs
Conclusions
• Quantitative ultrasound fetal lung maturity analysis predicted neonatal respiratory
morbidity with an accuracy comparable to current tests using amniotic fluid.
• Results being validated in international multicenter trial
(n>700)
www.medicinafetalbarcelona.org/
COMPROBACIÓN Y CORTICOIDES PARA MADURACIÓN PULMONAR FETAL
INDICACIÓN DE FINALIZACIÓN
(o información sobre madurez pulmonar fetal)
<"35.0"sem"
≥"35.0"'"<39.0!!sem!
Finalización!indicada.!Condiciones!clínicas!permiten!demora!para!corticoides.!
Indicación!de!finalización!no!absoluta!pero!opción!razonable!(1).!
"
Ha"recibido"corticoides"
y"quantusFLM®"disponible"
!(si!no!disponible,!administrar!corticoides!de!
acuerdo!con!recomendaciones)!!
BAJO!riesgo!de!
!morbilidad!respiratoria!neonatal*!
Programar!
finalización
N
N
NO"ha"recibido"corticoides:!!corticoides.!
!
"
Si!inducción!del!parto!y!<!37.0!sem!o!!
Si!CS!electiva!y!<!39.0!sem!
A!partir!del!día!siguiente!a!la!!2ª!dosis:!
BAJO!riesgo!de!
!morbilidad!respiratoria!neonatal*!
ALTO!riesgo!de!
morbilidad!respiratoria!neonatal*
Según!indicación!y!EG,!considerar:!
N!demorar!!3N7!días!la!finalización!y/o!!
N!tanda!o!dosis!única!o!multiple!de!corticoides!(si!<!35.0sem)!y/o!!
N!reevaluar!quantusFLM®!en!1!sem!o!
N!si!se!requiere!finalizar!a!pesar!de!inmadurez:!informar!neonatología!
!
*Morbilidad!respiratoria!neonatal!=!incluye!síndrome!de!distrés!respiratorio!y!taquipnea!
transitoria!neonatal
Programar!
finalización
(1)"Ejemplos"de"situaciones"potenciales":"
NHipertensión!crónica!o!diabetes!de!difícil!control.!
NBalance!hídrico!positive!con!discomfort!severo!materno.!
NColestasis!muy!sintomática!sin!respuesta!a!tratamiento.!
NPreeclampsia!leve!o!CIR!tardío!estadío!I!con!MAO.!
NPlacenta!previa!con!sangrado!intermitente!moderado!y!multiples!ingresos.!
PROTOCOLS DE MEDICINA FETAL I PERINATAL
4/4
22
36.0w, 38y, IVF
Chronic HT + poorly controlled diabetes. Edema with maternal discomfort
No absolute medical indication.
¿RISK NRM?
BASELINE: AT 36W = 6%
INDIVIDUALIZED: TEST LUNG MATURITY
(*IF CORTICOIDS REDUCE
40% RISK)
LOW RISK
=2%
HIGH RISK
=36%
Delivery.
Risk probably higher than waiting.
Wait 1w and repeat test
Obtención de imágenes
(ecografía)
www.medicinafetalbarcelona.org/
Envío de imágenes a
la app dggdf ®
para análisis
Informe de
resultados