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�info@transmuralbiotech.com.

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

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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)