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Application of Super-Resolution Ultrasound (SRUS) in Liver Tumor (SRUS)

2026年7月12日 更新者:WenLi Zhang、Eastern Hepatobiliary Surgery Hospital

The macroscopic vascular supply of liver tumors varies considerably according to histological subtype, lesion size, and disease stage. Current clinical imaging modalities primarily characterize liver tumors based on their macroscopic vascular perfusion patterns. Conventional color Doppler ultrasonography enables qualitative assessment of tumor vascularity, facilitates the differentiation of benign from malignant hepatic lesions, delineates the anatomical relationship between tumors and major intrahepatic vessels, and detects vascular invasion. Nevertheless, these macroscopic vascular characteristics arise from complex microvascular architectures, including vascular distribution patterns, microvessel density, vessel morphology and tortuosity, blood flow velocity, and flow direction. Despite the critical role of tumor microcirculation in tumor progression and therapeutic response, the heterogeneity of microvascular hemodynamics among different liver tumors remains inadequately characterized.

The emergence of Super Resolution Ultrasound Imaging (SRUS) has markedly advanced ultrasound imaging by overcoming the acoustic diffraction limit, enabling visualization of microvessels with diameters as small as approximately 20 μm. Unlike conventional ultrasound techniques, SRUS preserves the inherent advantages of ultrasound, including deep tissue penetration and a large field of view, while achieving an approximately tenfold improvement in spatial resolution. This unique combination effectively bridges the long-standing gap between imaging depth and spatial resolution in vascular imaging. Furthermore, by localizing and tracking individual circulating microbubbles,SRUS enables quantitative assessment of microvascular blood flow velocity over a broad dynamic range without Doppler angle dependence. Consequently, super-resolution ultrasound imaging offers an unprecedented opportunity to characterize and compare the microvascular hemodynamic features of benign and malignant liver lesions, thereby improving the accuracy of preoperative differential diagnosis, tumor staging, therapeutic response assessment, and prognostic evaluation.

調査の概要

詳細な説明

The macroscopic vascular supply of liver tumors varies considerably according to histological subtype, lesion size, and disease stage. Current clinical imaging modalities primarily characterize liver tumors based on their macroscopic vascular perfusion patterns. Conventional color Doppler ultrasonography enables qualitative assessment of tumor vascularity, facilitates the differentiation of benign from malignant hepatic lesions, delineates the anatomical relationship between tumors and major intrahepatic vessels, and detects vascular invasion. Nevertheless, these macroscopic vascular characteristics arise from complex microvascular architectures, including vascular distribution patterns, microvessel density, vessel morphology and tortuosity, blood flow velocity, and flow direction. Despite the critical role of tumor microcirculation in tumor progression and therapeutic response, the heterogeneity of microvascular hemodynamics among different liver tumors remains inadequately characterized.

The emergence of Super Resolution Ultrasound Imaging (SRUS) has markedly advanced ultrasound imaging by overcoming the acoustic diffraction limit, enabling visualization of microvessels with diameters as small as approximately 20 μm. Unlike conventional ultrasound techniques, SRUS preserves the inherent advantages of ultrasound, including deep tissue penetration and a large field of view, while achieving an approximately tenfold improvement in spatial resolution. This unique combination effectively bridges the long-standing gap between imaging depth and spatial resolution in vascular imaging. Furthermore, by localizing and tracking individual circulating microbubbles,SRUS enables quantitative assessment of microvascular blood flow velocity over a broad dynamic range without Doppler angle dependence. Consequently, super-resolution ultrasound imaging offers an unprecedented opportunity to characterize and compare the microvascular hemodynamic features of benign and malignant liver lesions, thereby improving the accuracy of preoperative differential diagnosis, tumor staging, therapeutic response assessment, and prognostic evaluation.

研究の種類

観察的

入学 (推定)

350

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。

研究連絡先

研究連絡先のバックアップ

  • 名前:Jing He
  • 電話番号:+86 18244242460
  • メール:G174265@163.com

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

確率サンプル

調査対象母集団

Liver tumor patients treated in the outpatient and inpatient departments of the Third Affiliated Hospital of the Naval Medical University.

説明

Inclusion Criteria:

  1. Any gender, 18 years or older;
  2. People newly diagnosed with liver tumors, including:

    ① Hepatocellular carcinoma; ② Cholangiocarcinoma; ③ Liver metastases; ④ Liver hemangioma; ⑤ Focal nodular hyperplasia of the liver.

  3. Need to have a contrast-enhanced ultrasound as part of routine care;
  4. Willing to join this study and sign the informed consent after discussing it with the doctor.

Exclusion Criteria:

  1. During the data collection process, if the participant is unable to cooperate fully, preventing the collection from being completed;
  2. If the skin in the collection area is broken or scabbed, or if there's too much ascites in the abdominal cavity interfering with sound signal penetration, making data collection impossible;
  3. Previous puncture biopsy or other treatments for existing liver malignant tumors;
  4. Patients with a history of allergy, allergic constitution, or severe intolerance to sulfur hexafluoride or other components of the ultrasound contrast agent;
  5. Patients who refuse to participate in this study;
  6. Any uncontrollable comorbidities that could limit the patient's adherence to the study requirements or affect their ability to sign the written informed consent;
  7. Poor overall condition or inability to tolerate relevant examinations;
  8. Participants whom the researcher deems unsuitable for inclusion in the study

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

コホートと介入

グループ/コホート
介入・治療
Observation group
Patients newly diagnosed with benign or malignant liver tumors
Perform super-resolution ultrasound imaging on the study population, record and calculate characteristic hemodynamic and morphological parameters, and analyze microvascular flow patterns.

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
Vascular parameters in different types of benign and malignant liver tumors
時間枠:At the time of initial diagnostic imaging (baseline), with pathological confirmation from subsequent surgical resection or biopsy obtained during the same hospitalization period.
Assessing the differences in vascular parameters between different types of benign and malignant liver tumors
At the time of initial diagnostic imaging (baseline), with pathological confirmation from subsequent surgical resection or biopsy obtained during the same hospitalization period.

二次結果の測定

結果測定
メジャーの説明
時間枠
Differences in treatment effectiveness between patient subgroups
時間枠:From date of treatment initiation until the date of first documented pathological or imaging response assessment, assessed up to 12 months

Treatment effectiveness is assessed using two different methods depending on the treatment modality:

Pathological assessment (for patients who undergo surgical resection):

A. Pathological complete response (pCR): no viable tumor cells detected in the postoperative specimen; B. Major pathological response (MPR): ≥50% reduction in the proportion of viable tumor cells compared to the baseline pretreatment specimen;

Imaging assessment based on mRECIST criteria (for patients who do not undergo surgery):

A. Complete Response (CR): disappearance of any intratumoral arterial enhancement in all target lesions B. Partial Response (PR): ≥30% decrease in the sum of diameters of viable target lesion C. Progressive Disease (PD): ≥20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters recorded since treatment started D. Stable Disease (SD): insufficient decrease to qualify for PR, and insufficient increase to qualify for PD

From date of treatment initiation until the date of first documented pathological or imaging response assessment, assessed up to 12 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。

捜査官

  • スタディチェア:Hui Liu, Professor、Eastern Hepatobiliary Surgery Hospital

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 (推定)

2026年7月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年7月3日

QC基準を満たした最初の提出物

2026年7月12日

最初の投稿 (実際)

2026年7月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月16日

QC基準を満たした最後の更新が送信されました

2026年7月12日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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