Ultrasound Evaluation of Crohn's Disease

NCT03235180 | Terminated Phase 4 Results FDA Device

• 1 other identifier: 17-001175
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Change in Shear Wave Speed

  Shear wave speed is a measure of small bowel stiffness; this will be measured on the General Electric (GE) Logiq E9 Ultrasound Scanner.

  baseline, 6 months

• Change in Vessel Density

  Vessel density is a measure of the vascularity of the bowel. It is the percentage of pixels in the bowel lesion with blood flow compared to the total area of the lesion. This will be measured with the Verasonics Ultrasound Scanner.

  baseline, 6 months

Study Arms (1)

Crohn's Disease Subjects

EXPERIMENTAL

Subjects will receive ultrasound exams of the bowel with 2 different machines (Ultrasound Elastography and Ultrasound Vascularity) at three time points: baseline, 4 weeks, and 6 months. The ultrasound exams will be performed at first with no contrast agent, and then ultrasound measurements will be repeated with 1-2 ml of Sulfur Hexafluoride, a contract agent. Subjects also will receive Magnetic Resonance Enterography (MRE) exams at baseline and 6 months as part of their clinical care.

Drug: Sulfur Hexafluoride; Device: Ultrasound Elastography; Device: Ultrasound Vascularity; Device: Magnetic Resonance Enterography (MRE)

Interventions

Sulfur Hexafluoride DRUG

Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.

Also known as: Lumason

Crohn's Disease Subjects

Ultrasound Elastography DEVICE

Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Also known as: GE Logiq E9 Ultrasound Scanner

Crohn's Disease Subjects

Ultrasound Vascularity DEVICE

Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.

Also known as: Verasonics

Crohn's Disease Subjects

Magnetic Resonance Enterography (MRE) DEVICE

Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

Crohn's Disease Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Crohn's disease patients with involvement of terminal ileum (thickness \> 3mm).

You may not qualify if:

• Patients with change of medicine or going to surgery over the 6-months follow-up period.
• Patients with unreliable ultrasound images due to conditions such as large body habitus or poor ultrasound imaging window.
• Adults lacking capacity to consent.
• Vulnerable subjects such as prisoners.
• Pregnant women and nursing mothers.
• Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
• Patients with history of hypersensitivity allergic reactions to ultrasound contrast agents.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Crohn Disease

Interventions

Sulfur Hexafluoride

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Results Point of Contact

• Title: Shigao Chen, Ph.D.
• Organization: Mayo Clinic

Chen.Shigao@mayo.edu

507-284-3703

Study Officials

• Shigao Chen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: June 16, 2017
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)