このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2015年5月31日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

195

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Hong Kong
      • Hong Kong、Hong Kong、中国
        • Tsan Yuk Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

確率サンプル

調査対象母集団

  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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:ケースコントロール

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Kah Bik Cheong, BSc(Hons), MMedSc, MBBS、The University of Hong Kong
  • スタディディレクター:Kwok Yin Leung, MBBS, FHKAM、The University of Hong Kong

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年3月1日

一次修了 (実際)

2009年6月1日

研究の完了 (実際)

2009年8月1日

試験登録日

最初に提出

2009年1月21日

QC基準を満たした最初の提出物

2009年1月21日

最初の投稿 (見積もり)

2009年1月22日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年6月2日

QC基準を満たした最後の更新が送信されました

2015年5月31日

最終確認日

2015年5月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する