CEH-EUS for Differentiating GISTs and Leiomyomas: A Multicenter Prospective Self-Controlled Study

NCT07106411 · tracked via the Priya Life Science China tracker

Sponsor

Huazhong University of Science and Technology

Phase

Observational

Started

2025-08

Last updated

2025-08-06

Condition(s) studied

Submucosal TumorGastrointestinal Stromal Tumor (GIST)Leiomyoma

Investigational drug(s) / intervention(s)

Endoscopic UltrasoundContrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)

Endoscopic Ultrasound: Conventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS): CEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

Study summary

The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years and ≤ 85 years; * Subepithelial lesion in the gastrointestinal tract identified under white-light endoscopy and scheduled for CEH-EUS examination to determine the nature of the lesion; * EUS image quality meets the following quality control standards: 1. Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan); 2. Image acquisition: Five EUS still images clearly displaying the lesion and surrounding structures, including maximum lesion diameter, originating layer, Doppler signals, and internal echo characteristics; a 15-second video clearly demonstrating the lesion without any artificial annotations (e.g., scale, needle, Doppler signal, elastography, etc.); 3. CEH-EUS procedure: Use of extended pure harmonic detection (Ex-PHD) mode with mechanical index (MI) adjusted to 0.3; 2.4 mL of SonoVue contrast agent is injected via the elbow vein within 2-3 seconds, followed by a 5 mL saline flush; real-time dynamic image acquisition continues for 120 seconds, and video recording is collected. * Patients with GIST confirmed by surgical or endoscopic resection pathology, and patients with leiomyoma confirmed by surgical resection, EUS-guided tissue sampling, or other biopsy techniques; * Written informed consent is obtained. Exclusion Criteria: * Age \<18 years or \>85 years; * Hemoglobin level ≤8.0 g/dL; * Known allergy or hypersensitivity to ultrasound contrast agents; * Pregnant women; * Severe cardiopulmonary dysfunction that precludes tolerance of endoscopic ultrasound examination; * Inability to provide written informed consent (e.g., due to psychiatric disorders or substance abuse).

Primary outcome measure(s)

Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma — Within 1 month after final histopathological diagnosis
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors — Within 1 month after final histopathological diagnosis
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

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Other trials for the same condition

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A Study of HQP1351 in Patients With GIST or Other Solid Tumors Recruiting

Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients Active, not recruiting

Multicenter Observational Study of Multimodal AI for Upper GI Mesenchymal Tumor Diagnosis Recruiting

Mesenteric Vascular Preconditioning Combined With Laparoscopic and Endoscopic Cooperative Surgery for Submucosal Tumor at the Gastroesophageal Junction Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07106411 on ClinicalTrials.gov ↗ ← All trials in China