Trial Outcomes & Findings for Ultrasound Evaluation of Crohn's Disease (NCT NCT03235180)

NCT ID: NCT03235180

Last Updated: 2021-11-10

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: baseline, 6 months
• Results posted on: 2021-11-10

Participant Flow

Participant milestones

Measure	Crohn's Disease Subjects 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. Sulfur Hexafluoride: 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. Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Evaluation of Crohn's Disease

Baseline characteristics by cohort

Measure	Crohn's Disease Subjects n=9 Participants 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. Sulfur Hexafluoride: 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. Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Age, Continuous	40.7 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

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

Outcome measures

Measure

Crohn's Disease Subjects n=9 Participants 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. Sulfur Hexafluoride: 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. Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

Change in Shear Wave Speed

8.42 KPa Standard Deviation 4.07

PRIMARY outcome

Timeframe: baseline, 6 months

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.

Outcome measures

Measure

Crohn's Disease Subjects n=9 Participants 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. Sulfur Hexafluoride: 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. Ultrasound Elastography: Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Ultrasound Vascularity: Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast. Magnetic Resonance Enterography (MRE): Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.

Change in Vessel Density

14.1 percentage of pixels Standard Deviation 6.18

Adverse Events

Crohn's Disease Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shigao Chen, Ph.D.

Mayo Clinic

Phone: 507-284-3703

Email: Chen.Shigao@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place