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Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies

2015년 5월 31일 업데이트: The University of Hong Kong

Use of 3D/4D Ultrasound in the Evaluation of Fetal Anomalies - The Use of Volumetry by Three Dimensional Ultrasound in the First Trimester

Volumetry measurements can be a potential clinical use as non-invasive tools in prenatal diagnosis and screening and helps to reduce the risk and complications of invasive procedures. 3DUS volumetry gives more precise results than 2DUS volumetry measurements, particularly, of irregularly shaped objects.

연구 개요

상세 설명

Conventionally volume measurements can be made by using multiplanar or VOCALTM (Virtual Organ Computer-aided AnaLysis). Recently, a new technique, XI VOCALTM (eXtended Imaging VOCAL) has been described. Combined with the inversion mode, measurements for the liquid-filled structures can also be made. The potential use in clinical diagnosis and prediction of pathologies of volume measurements particularly in the first trimester are yet to be investigated.

3D ultrasound is found to be superior to 2D parameter in volumetry measurement. However, currently, there are still very few studies done to evaluate the potential use of volumetry measurement in clinical practice, especially of the validity and reproducibility of XI VOCALTM; and the variation of results obtained within different ultrasound machines. Due to the potential use of volumetry measurements in clinical practice, the accuracy in volumetry measurement is very important and the development of new technique need to be fully explored so that its benefits can be fully used for the contribution of clinical practice.

So far no research has been done to evaluate the difference in the results obtained between different ultrasound machines, in particularly for volumetry measurements. This is important because if there is no significant difference in results between difference machines, we can accumulate the results from these machines for a study, which can include a more variety of samples. Furthermore, it will be much easier to compare results of one machine with another for similar studies.

Both Voluson 730 and Accuvix have been used widely in research studies on 3D volumetry but comparison of the results obtained from these two machines have not been done. We do not know whether the results generated from one machine can be extrapolated to the other machine for clinical or research purpose. Thus more research needs to be done in this area.

Thus, this study is carried out to evaluate the potential use of the new modality of XI VOCALTM in the volumetry measurement of regular and irregular shaped objects, comparison of results obtained between different widely used machines, and the potential used of volumetry measurements in the prediction of common and important clinical pathologies such as αº-thalassemia.

연구 유형

관찰

등록 (실제)

195

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Hong Kong
      • Hong Kong, Hong Kong, 중국
        • Tsan Yuk Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

확률 샘플

연구 인구

  1. Use of XI VOCALTM in 3D fetal volumetry measurements,comparison with multiplanar and VOCALTM

    -restropective(2005-2007),30 singleton pregnancies,11-14 weeks' gestation, at risk of homozygous αº-thalassaemia.

  2. Use of XI VOCALTM in 3D placental volumetry measurements,comparison with multiplanar and VOCALTM

    -retrospective(2005-2007), 32 singleton pregnancies,11-14 weeks' gestation at risk of homologous alphaº thalassaemia.

  3. Comparison of 3DUS volumetry measurement between two models of ultrasound machine -prospective(December 2007-June 2008),30 singleton normal pregnancies,11-14 weeks' gestation.
  4. Use of 3DUS in fetal, gestational sac and placenta quotient measurement, fetuses at risk of homozygous αº-thalassemia(Hb Bart's disease) -retrospective(datasets July 2007-Dec 2008),singleton pregnancies,11-14 weeks' gestation,26 affected cases,34 unaffected cases,43 normal control.

설명

Inclusion Criteria:

For objective 1 and 2 - Samples are recruited from our prenatal diagnostic clinic at Ysan Yuk Hospital between 11-14 weeks' gestation. They are those who come for routine scan and those who are referred from the general antenatal clinics of the same hospital which pregnancies are at risk of homologous alphaº thalassaemia.

For objective 3 - Recruitment are the same as above except samples are obtained from normal pregnancy.

For objective 4 - Recruitment are the same as above. However, study is divided into intervention group and control group. For the intervention group, data is collected from pregnancies at risk of of homozygous αº-thalassemia while for the control group, data is collected from normal pregnancies.

Exclusion Criteria:

  • If women refuse to participate in the study
  • Patients with other co-existing illnesses

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 컨트롤

코호트 및 개입

그룹/코호트
Objective 1: XI VOCALTM in 3D fetal volumetry measurement
group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM
Objective 2: XI VOCALTM in 3D placental volumetry measurement
group 1: multiplanar; group 2: VOCALTM; group 3: XI VOCALTM
Objective 3: Comparison between 2 ultrasound machine
  1. intramachine reliability for (i)fetal, (ii)gestational sac and (iii)placenta volumetry measurement for (a)multiplanar and (b)VOCALTM:- group 1:Accuvix; group 2:Voluson 730
  2. intermachine reliability for fetal, gestational sac and placenta volumetry measurement for (a)multiplanar and (b)VOCALTM for Accuvix and Voluson 730
Objective 4:3D volumetry in fetuses at risk of Hb Bart's
Measurement of fetal, gestational sac and placenta volume per CRL quotient using multiplanar technique:- group 1: affected; group 2: unaffected

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective 1:The use of XI VOCALTM in 3D volumetry measurements of fetal head and trunk of fetuses from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
기간: 18 months

The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of fetal volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting.

The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used.

We hypothesized XI VOCALTM can be used interchangeably with multiplanar and VOCALTM technique if similar number of steps are used in the measurement of regular objects such as fetal head and trunk.

18 months
Objective 2:The use of new modality of XI VOCALTM in 3D volumetry measurements of placenta from 11 to 14 weeks gestation and known volume phantoms and its comparison with the conventional multiplanar and VOCALTM technique
기간: 18 months

The objectives of this study are to compare (1) the reproducibility of multiplanar and the VOCALTM technique for 3DUS measurement of placenta volume with the new modality XI VOCALTM, and (2) validity of these three techniques using an in-vitro setting.

The hypothesis of the study are (1) the results obtained from the new modality of XI VOCALTM is interchangeable with multiplanar and VOCALTM with similar number of steps used and (2) validity between XI VOCALTM is comparable to multiplanar and VOCALTM with similar number of steps used.

We hypothesized that XI VOCALTM can be used interchangeably with the other two techniques for the volumetry measurement of irregular objects such as placenta if similar number of steps is used.

18 months
Objective 3:The use of 3DUS in the volumetry of first trimester pregnancy and in vitro study: comparison between two models of ultrasound machine
기간: 18 months

The objective of the present study are to compare (1) the reproducibility of these two machines for fetal, gestational sac and placenta 3D volumetry using multiplanar (1-mm interval) and Virtual Organ Computer-Aided Analysis (VOCAL)TM (30º) technique and (2) validity of these two machines using an in-vitro setting.

Hypothesis of the study: 3D volumetry measurement of fetal, gestational sac and placenta volume of fetuses at 11 to 14 weeks' gestation with Voluson 730 is interchangeable with the measurement using Accuvix ultrasound machine.

We hypothesized that the Accuvix machine could be used interchangeably with Voluson 730 for both multiplanar and VOCALTM for fetal, gestational sac and placenta volumetry measurement.

18 months
Objective 4:The use of 3DUS in the measurement of fetal, gestational sac and placenta quotient of fetuses at risk of homozygous αº-thalassemia (Hb Bart's disease) at 11 to 14 weeks' gestation
기간: 18 months

This study was carried out to evaluate the use of fetal, gestational sac and placenta volume measured by three-dimensional (3D) ultrasound in predicting fetal homozygous αº-thalassemia (Hb-Bart's disease).

Hypothesis of the study: Measurement of 3D volume of the fetal, gestational sac and placenta quotient can be used as a useful tool as 2D parameter for the prediction of fetuses of homozygous alpha0-thalassaemia (Hb Bart's disease) at 11 to 14 weeks' gestation.

We hypothesized that 3D volumetry measurement of the fetal, gestational sac and placenta quotient can serve as a useful tool as 2D parameter for the prediction of homozygous alpha0-thalassaemia (Hb Bart's disease) fetuses at 11 to 14 weeks' gestation.

18 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Kah Bik Cheong, BSc(Hons), MMedSc, MBBS, The University of Hong Kong
  • 연구 책임자: Kwok Yin Leung, MBBS, FHKAM, The University of Hong Kong

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 3월 1일

기본 완료 (실제)

2009년 6월 1일

연구 완료 (실제)

2009년 8월 1일

연구 등록 날짜

최초 제출

2009년 1월 21일

QC 기준을 충족하는 최초 제출

2009년 1월 21일

처음 게시됨 (추정)

2009년 1월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 5월 31일

마지막으로 확인됨

2015년 5월 1일

추가 정보

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