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Clinical research protocol for evaluating the activity of Crohn's disease and predicting therapeutic efficacy based on multimodal ultrasound technology with microbubble contrast-enhanced ultrasound

Clinical research protocol for evaluating the activity of Crohn's disease and predicting therapeutic efficacy based on multimodal ultrasound technology with microbubble contrast-enhanced ultrasound

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113553
Enrollment
Unknown
Registered
2025-12-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Index test:Super-Resolution Contrast-Enhanced Ultrasound?Contrast-enhanced Ultrasound?2D Ultrasound?Color Doppler Flow Imaging?Shear Wave Elastography

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old, gender not limited; 2.Comply with the "Diagnostic Criteria for Crohn's Disease (2024 Edition)" of China, and be diagnosed with Crohn's disease through endoscopy, imaging (CT/MRI), and pathology; 3.The patient initiates a new treatment plan, including biologics or immunosuppressant therapy; 4.Endoscopic examination was performed within the last month; 5.Be capable of cooperating to complete multimodal ultrasound examinations including contrast-enhanced ultrasound; 6.Voluntarily sign the informed consent form and agree to participate in the research and data collection;

Exclusion criteria

Exclusion criteria: 1.Contrast agent allergy; 2.Complicated with severe complications or contraindications; 3.Pregnant or lactating women, and those with severe renal insufficiency; 4.Combined with other intestinal diseases, such as intestinal tuberculosis, intestinal tumors, or systemic immune diseases; 5.Abdominal obesity, BMI>=30kg/m², leads to poor ultrasound penetration and poor display of intestinal wall structure; 6.Poor image quality of contrast-enhanced ultrasound: During the examination, unstable images are caused by breathing and intestinal peristalsis, which affects the accuracy of quantitative parameters; 7.Incomplete data: The colonoscopy failed to reach the target section or the clinical data was incomplete; 8.Those who have undergone intestinal surgery within the past three months;

Design outcomes

Primary

MeasureTime frame
Disease remission period;

Countries

China

Contacts

Public ContactLi Gong

Nanjing Drum Tower Hospital

asdfghjklpoiu@1712.com+86 25 83106666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026