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E Bonet, M Palacio, T Cobo, A Perez, M Lopez, E Gratacos
www.fetalmedicinebarcelona.org/
Lung maturity prediction by quantitative ultrasound analysis
BCNatal – Barcelona Center of Maternal-Fetal and Neonatal Medicine!Hospital Clinic and Hospital Sant Joan de Déu, University of Barcelona!
www.fetalmedicinebarcelona.org
Non-invasive assessment of fetal lung maturity
www.medicinafetalbarcelona.org/
Objective To evaluate the performance of a novel method to predict neonatal respiratory morbidity based on quantitative analysis of fetal lung ultrasound.
Maeda 1999 Lung vs liver grey-level !Prakash 2002 Ultrasound image features. !Tekesin 2004 Quantitative US features !Cobo 2012, Palacio 2013 Texture Analysis
www.medicinafetalbarcelona.org/
Quantus FLM (texture analysis method)
MethodsMachine Learning Approach
Risk estimation
Texture Extractor (developed w>106)
Algorithms (trained >1500)
• N=144 • Singleton pregnancies • 29.0 - 38.6 w • Axial thoracic section
Neonatal Respiratory Morbidity (*): • Respiratory Distress Syndrome • Transient tachypnea of newborn
(*) RDS: Respiratory symptoms (eg, grun7ng, flaring, tachypnea, retrac7ons), O2 requirement + chest Rx + NICU admission TT: chest Rx impression + clinical diagnosis by clinician in charge. JAMA 2010
Patient�&�Provider�Informationwww.quantusFLM.com
Sabino�Arana�38�1Ͳ108028�Barcelona,�SpainCIF:�BͲ65084675
PATIENT NAME: CLINIC NAME:
PATIENT ID: REFERRING/ORDERING CLINICIAN:
QUANTUSFLM�ID: REPORT�DATE:�(dd/mm/yyyy)
Name�Surname
NHC12345678
btechͲ123
Complete�Center�Name
Clinician�Name�Surname
01/01/2000
Sample�Information
GESTATIONAL�AGE:
US�ACQUISITION�DATE:(dd/mm/yyyy)
REQUEST�DATE:(dd/mm/yyyy hh:mm)
##�weeks #�days
01/01/2000
01/01/2000�00:00
Test�Result���NEONATAL�RESPIRATORY�MORBIDITY
QUANTUSFLM�ID:
RESULT:
Theoretical risk for ##�weeks of�gestation:
quantusFLM risk:
RECOMMENDATION:(dd/mm/yyyy)
AUTHORIZED�SIGNER/S:
Technical�Responsible:Elisenda Bonet�i�Carné,�MSc
Imatge Firma
CLINICAL�DATA�Ͳ SPECIFICATIONSAccuracy 87%�(95%�CI:82Ͳ90%)
Sensitivity 91%�(95%�CI:77Ͳ98%)
Specificity 86%�(95%�CI:82Ͳ90%)
Positive Predictive Value 47%�(95%�CI:35Ͳ59%)
Negative Predictive Value 98%�(95%�CI:96Ͳ99%)
TEST DESCRIPTIONquantusFLM™ offers an automatic assessment of neonatal respiratory morbidity risk using an ultrasoundimage of the lateral axial transverse section of the fetal thorax at the level of the 4Ͳchamber section of thefetal heart. quantusFLM™ is based on quantitative ultrasound texture analysis to extract information fromultrasound images and a classifier which uses the extracted information to assess the risk. Test resultdepends on the delineation of the fetal lung and incorporated the gestational age. Neonatal respiratorymorbidity 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 neitherintended nor validated for use in pregnancies with fetal structural abnormalities, chromosomalabnormalities, multiple pregnancies or maternal BMI>35. This result should not be considered as a finalindication but as additional information to be considered in evaluation of the patient.
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].
REFERENCE:�Quantitative ultrasound texture analysis of�fetal�lung to�predict neonatal�respiratory morbidity.�UOG�(2014)
NonͲInvasive Assessment of�therisk of�Neonatal�Respiratory morbidity
Graphic�Test�Result NEONATAL�RESPIRATORY�MORBIDITY�RISK
HIGH LOWRISK RISK
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
Theoretical Risk*
quantusFLM Risk
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
LOW�RISK
##.#�%
##.#�%
Review results with patient
btechͲ123
www.fetalmedicinebarcelona.org/
Pa7ents 144
Maternal age, y 32.8 (5.7)
Nuliparity 86 (59.7)
Cor7costeriods 52/144 (36.1)
GA at scan, w (d) 36.0 (3.3)
28.0 to < 33.6 38/144 (26.4)
≥ 34.0 106/144 (73.6)
Respiratory Morbidity 20.1 % (29/144)Results
Sensi7vity 86,2Specificity 86,9PPV 62,5NPV 96,2
0
20
40
60
80
100
Sensitivity Specificity PPV NPV
98
19
66
88
95
37
84
72
96
63
8787
Quantus L/S ratio Lamellar Body
www.medicinafetalbarcelona.org/
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>1,000)