Crohn's DiseasePhase 1/2NCT02061163
Contrast-Enhanced Ultrasound in Human Crohn's Disease
A Phase 1/2 study testing Contrast Enhanced Ultrasound and Optison in people with Crohn's Disease, run by University of Michigan at 1 site in United States.
Trial summary
To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's disease. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Contrast Enhanced Ultrasound and Optison
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 10 years of age and older
- Have been diagnosed with small bowel Crohn's disease
- Are receiving medical therapy for Crohn's disease
- Are scheduled for surgery (bowel resection) OR
- Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.
Who cannot join
- Patients under the age of 10
- Are pregnant or breast feeding
- Are significantly overweight - BMI >35-40
- Have an inability to understand the consent
- Have prior allergic-like reaction or other adverse reaction to microbubble contrast agent
- Hypersensitivity to perflutren, blood, blood products or albumen
Show all 9Show fewer
- Have a cardiac shunt
- Known unstable cardiac condition such as history of a heart attach, irregular heartbeat, congestive heart failure, etc.
- Known acute or chronic kidney disease, moderate/severe lung disease or acute or chronic liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease
To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's disease.
Read the detailed description
Crohn's disease (CD) is an inflammatory condition that affects the intestinal tract (large and small bowels). Some patients with CD may get swelling of the intestinal tract (inflammation) or scarring of the intestinal tract (fibrosis). Fibrosis develops because of chronic injury. Both inflammation (swelling) and fibrosis (scarring) can cause the bowel to narrow, which can lead to the bowel becoming blocked. The long-term goal of this project is to develop new noninvasive radiology imaging tests that can show the difference between bowel wall inflammation and fibrosis. Currently there are no imaging tests that can do this reliably.
Current imaging methods (CT and MRI) that are ordered to help diagnose and follow-up CD are excellent at showing inflammation, but are not accurate for finding fibrosis. CT also exposes patients to small amounts of radiation, and both CT and MRI are costly. We are therefore studying ultrasound imaging, as it is more cost-effective and does not expose patients to radiation. CEUS uses microbubbles in a solution that are injected into a vein in one of the arms. This allows doctors to see the blood flow to parts of the body. This microbubble contrast agent (dye) is called Optison. Another imaging method, called shear wave elastography, uses sound waves to noninvasively measure the stiffness of structures in the body.
It is important to be able to tell the difference between inflammation and fibrosis in Crohn's disease, because narrowing of the bowel due to inflammation generally responds well to medications, whereas narrowing caused by fibrosis does not respond well to medications and may require surgery.
- Conditions
- Crohn's Disease
- Being tested
- Contrast Enhanced Ultrasound, Optison
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced UltrasoundDevice
Subjects with Crohn's disease will undergo contrast enhanced ultrasound imaging with shear wave elastography. Both CEUS and shear wave elastography will be performed using FDA approved ultrasound machines.
OptisonDrug
Optison is a microbubble contrast agent (dye) that will be injected during the CEUS imaging. Optison is FDA-approved for use in heart ultrasounds but not approved for use in bowel ultrasounds. Its use in this study is considered investigational (off-label).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Crohn's disease | Experimental | Contrast Enhanced Ultrasound Optison Receives: Device: Contrast Enhanced Ultrasound; Drug: Optison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS
CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: PI leaving UM at the end of the month
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Dillman M.D., University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061163
- Sponsor's protocol ID
- HUM00080030
- Status last verified
- Jun 2015
- First submitted
- 6 Feb 2014
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease
- ClinicalTrials.gov ID
- NCT02061163
- Acronym / sponsor ID
- HUM00080030
- Conditions
- Crohn's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving UM at the end of the month
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's disease.
Detailed description
Crohn's disease (CD) is an inflammatory condition that affects the intestinal tract (large and small bowels). Some patients with CD may get swelling of the intestinal tract (inflammation) or scarring of the intestinal tract (fibrosis). Fibrosis develops because of chronic injury. Both inflammation (swelling) and fibrosis (scarring) can cause the bowel to narrow, which can lead to the bowel becoming blocked. The long-term goal of this project is to develop new noninvasive radiology imaging tests that can show the difference between bowel wall inflammation and fibrosis. Currently there are no imaging tests that can do this reliably.
Current imaging methods (CT and MRI) that are ordered to help diagnose and follow-up CD are excellent at showing inflammation, but are not accurate for finding fibrosis. CT also exposes patients to small amounts of radiation, and both CT and MRI are costly. We are therefore studying ultrasound imaging, as it is more cost-effective and does not expose patients to radiation. CEUS uses microbubbles in a solution that are injected into a vein in one of the arms. This allows doctors to see the blood flow to parts of the body. This microbubble contrast agent (dye) is called Optison. Another imaging method, called shear wave elastography, uses sound waves to noninvasively measure the stiffness of structures in the body.
It is important to be able to tell the difference between inflammation and fibrosis in Crohn's disease, because narrowing of the bowel due to inflammation generally responds well to medications, whereas narrowing caused by fibrosis does not respond well to medications and may require surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with Crohn's disease | Experimental | Device: Contrast Enhanced Ultrasound, Drug: OptisonContrast Enhanced Ultrasound Optison |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 10 years of age and older
- Have been diagnosed with small bowel Crohn's disease
- Are receiving medical therapy for Crohn's disease
- Are scheduled for surgery (bowel resection) OR
- Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.
Key exclusion criteria (9 listed)
- Patients under the age of 10
- Are pregnant or breast feeding
- Are significantly overweight - BMI >35-40
- Have an inability to understand the consent
- Have prior allergic-like reaction or other adverse reaction to microbubble contrast agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced UltrasoundSubjects with Crohn's disease will undergo contrast enhanced ultrasound imaging with shear wave elastography. Both CEUS and shear wave elastography will be performed using FDA approved ultrasound machines. | Device | Subjects with Crohn's disease |
| OptisonOptison is a microbubble contrast agent (dye) that will be injected during the CEUS imaging. Optison is FDA-approved for use in heart ultrasounds but not approved for use in bowel ultrasounds. Its use in this study is considered investigational (off-label). | Drug | Subjects with Crohn's disease |
Primary outcome
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS
Time frame: 2 years
CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Contrast Enhanced Ultrasound and Optison in people with Crohn's Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.