Crohn DiseaseNCT03492944

Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason

An observational study of Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease Read more about this study

Who is it for?: Ages 10 to 18 years
Conditions the study is for: Crohn Disease
What is being tested?: Ultrasound Microbubble Contrast Agent and Ultrasound Imaging
Type of treatment: Injection or infusion, Medical device
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 6 Mar 2020to 30 Oct 2025
Phase: Observational
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 to 18 years
All sexes
No healthy volunteers
Child, Adult

Study population: We plan to recruit approximately 25 subjects, 10-18 years of age, with known small bowel Crohn disease undergoing clinically indicated Computed Tomography Enterography (CTE) or Magnetic Resonance Enterography (MRE)imaging

Who may be able to join

histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation [either CT or MRI] and receiving medical therapy for Crohn's disease).
Between ages 10 and 18 years.
Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment

Who cannot join

Patients under the age of 10 or over the age of 18.
Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).
Known unstable cardiopulmonary conditions (including any history of acute myocardial infarction/acute coronary artery syndrome, arrhythmia, and congestive heart failure), ongoing acute or chronic kidney disease (eGFR <30 ml/min), moderate/severe chronic lung disease, and end-stage liver disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography

The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease

Read the detailed description

The proposed study will investigate the use of an FDA-approved ultrasound microbubble contrast agent (Lumason; Bracco Diagnostics) in pediatric and adult Crohn's disease patients undergoing either MR enterography (MRE, or MRI of the bowel) or CT enterography (CTE, or CT of the bowel). In April 2016, Lumason was FDA approved for intravenous administration and imaging of the liver in children. Imaging of the bowel will employ an identical administration method to that described for liver imaging, but the ultrasound transducer will be placed over the affected intestines as opposed to liver.

Conditions: Crohn Disease
Being tested: Ultrasound Microbubble Contrast Agent, Ultrasound Imaging
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrasound Microbubble Contrast AgentDrug
Also called Lumason
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
Ultrasound ImagingDevice
Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel

Study groups in NCT03492944
Study group	Role	What they receive
Ultrasound Microbubble Contrast Agent		All subjects will receive intravenous Lumason microbubble contrast agent; there is no comparative ultrasound contrast agent. Contrast Enhanced Ultrasound findings/results will be correlated with comparable, clinically performed, CTE/MRE findings/results Receives: Drug: Ultrasound Microbubble Contrast Agent; Device: Ultrasound Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Degree of bowel wall enhancement
Percent hyperenhancement (compared to normal bowel loops)
Measured: 2 years

Secondary outcomes (3)

Overall Disease Status for imaged section
status of inactive, mild activity, moderate activity and severe activity
Measured: 2 years
Degree of mesenteric inflammation
Inflammation assessed as none, mild, moderate, severe
Measured: 2 years
Maximum Bowel Wall Thickness
Measured
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 202030 Oct 2025

First posted10 Apr 2018
Study start6 Mar 2020
Primary completion12 Jun 2024
Study completion30 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Crohn DiseaseStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03492944
Sponsor's protocol ID: CIN_Lumason Crohns_001
Status last verified: Jun 2026
First submitted: 12 Feb 2018
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: Research data including identifying information about participants will only be accessible to CCHMC study personnel. De-identified data including images will be shared with scientists at Bracco Diagnostics. No identifiable data will be shared

Publications

Adler J, Punglia DR, Dillman JR, Polydorides AD, Dave M, Al-Hawary MM, Platt JF, McKenna BJ, Zimmermann EM. Computed tomography enterography findings correlate with tissue inflammation, not fibrosis in resected small bowel Crohn's disease. Inflamm Bowel Dis. 2012 May;18(5):849-56. doi: 10.1002/ibd.21801. Epub 2011 Jun 24.
PubMed 21710535
Girlich C, Jung EM, Huber E, Ott C, Iesalnieks I, Schreyer A, Schacherer D. Comparison between preoperative quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound and operative macroscopic findings and results of histopathological scoring in Crohn's disease. Ultraschall Med. 2011 Apr;32(2):154-9. doi: 10.1055/s-0029-1245398. Epub 2010 May 6.
PubMed 20449794
Quaia E, Migaleddu V, Baratella E, Pizzolato R, Rossi A, Grotto M, Cova MA. The diagnostic value of small bowel wall vascularity after sulfur hexafluoride-filled microbubble injection in patients with Crohn's disease. Correlation with the therapeutic effectiveness of specific anti-inflammatory treatment. Eur J Radiol. 2009 Mar;69(3):438-44. doi: 10.1016/j.ejrad.2008.10.029. Epub 2008 Dec 12.
PubMed 19070446
Wong DD, Forbes GM, Zelesco M, Mason R, Pawlik J, Mendelson RM. Crohn's disease activity: quantitative contrast-enhanced ultrasound assessment. Abdom Imaging. 2012 Jun;37(3):369-76. doi: 10.1007/s00261-011-9792-z.
PubMed 21830051
De Franco A, Di Veronica A, Armuzzi A, Roberto I, Marzo M, De Pascalis B, De Vitis I, Papa A, Bock E, Danza FM, Bonomo L, Guidi L. Ileal Crohn disease: mural microvascularity quantified with contrast-enhanced US correlates with disease activity. Radiology. 2012 Feb;262(2):680-8. doi: 10.1148/radiol.11110440. Epub 2011 Dec 12.
PubMed 22157203
Girlich C, Schacherer D, Jung EM, Schreyer A, Buttner R. Comparison between a clinical activity index (Harvey-Bradshaw-Index), laboratory inflammation markers and quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound in Crohn's disease. Eur J Radiol. 2012 Jun;81(6):1105-9. doi: 10.1016/j.ejrad.2011.02.054. Epub 2011 Mar 24.
PubMed 21439749
Ripolles T, Martinez MJ, Paredes JM, Blanc E, Flors L, Delgado F. Crohn disease: correlation of findings at contrast-enhanced US with severity at endoscopy. Radiology. 2009 Oct;253(1):241-8. doi: 10.1148/radiol.2531082269. Epub 2009 Jul 27.
PubMed 19635834
Malago R, D'Onofrio M, Mantovani W, D'Alpaos G, Foti G, Pezzato A, Caliari G, Cusumano D, Benini L, Pozzi Mucelli R. Contrast-enhanced ultrasonography (CEUS) vs. MRI of the small bowel in the evaluation of Crohn's disease activity. Radiol Med. 2012 Mar;117(2):268-81. doi: 10.1007/s11547-011-0783-5. Epub 2012 Jan 21.
PubMed 22271005
Quaia E, De Paoli L, Stocca T, Cabibbo B, Casagrande F, Cova MA. The value of small bowel wall contrast enhancement after sulfur hexafluoride-filled microbubble injection to differentiate inflammatory from fibrotic strictures in patients with Crohn's disease. Ultrasound Med Biol. 2012 Aug;38(8):1324-32. doi: 10.1016/j.ultrasmedbio.2012.04.008. Epub 2012 Jun 13.
PubMed 22698508
Schirin-Sokhan R, Winograd R, Tischendorf S, Wasmuth HE, Streetz K, Tacke F, Trautwein C, Tischendorf JJ. Assessment of inflammatory and fibrotic stenoses in patients with Crohn's disease using contrast-enhanced ultrasound and computerized algorithm: a pilot study. Digestion. 2011;83(4):263-8. doi: 10.1159/000321389. Epub 2011 Jan 28.
PubMed 21273775
Riccabona M, Avni FE, Damasio MB, Ording-Muller LS, Blickman JG, Darge K, Lobo ML, Papadopoulou F, Vivier PH, Willi U. ESPR Uroradiology Task Force and ESUR Paediatric Working Group--Imaging recommendations in paediatric uroradiology, part V: childhood cystic kidney disease, childhood renal transplantation and contrast-enhanced ultrasonography in children. Pediatr Radiol. 2012 Oct;42(10):1275-83. doi: 10.1007/s00247-012-2436-9. Epub 2012 Sep 22.
PubMed 23001574
Main ML, Ryan AC, Davis TE, Albano MP, Kusnetzky LL, Hibberd M. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). Am J Cardiol. 2008 Dec 15;102(12):1742-6. doi: 10.1016/j.amjcard.2008.08.019. Epub 2008 Oct 23.
PubMed 19064035
McCarville MB, Kaste SC, Hoffer FA, Khan RB, Walton RC, Alpert BS, Furman WL, Li C, Xiong X. Contrast-enhanced sonography of malignant pediatric abdominal and pelvic solid tumors: preliminary safety and feasibility data. Pediatr Radiol. 2012 Jul;42(7):824-33. doi: 10.1007/s00247-011-2338-2. Epub 2012 Jan 17.
PubMed 22249601
Dillman JR, Strouse PJ, Ellis JH, Cohan RH, Jan SC. Incidence and severity of acute allergic-like reactions to i.v. nonionic iodinated contrast material in children. AJR Am J Roentgenol. 2007 Jun;188(6):1643-7. doi: 10.2214/AJR.06.1328.
PubMed 17515388
Wang CL, Cohan RH, Ellis JH, Adusumilli S, Dunnick NR. Frequency, management, and outcome of extravasation of nonionic iodinated contrast medium in 69,657 intravenous injections. Radiology. 2007 Apr;243(1):80-7. doi: 10.1148/radiol.2431060554.
PubMed 17392249

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography
ClinicalTrials.gov ID: NCT03492944
Acronym / sponsor ID: CIN_Lumason Crohns_001
Conditions: Crohn Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: 6 Mar 2020 (actual)
Primary completion: 12 Jun 2024 (actual)
Study completion: 30 Oct 2025 (actual)
First posted: 10 Apr 2018 (actual)
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.

The investigators plan to compare contrast-enhanced ultrasound to CT and MRI for the detection and quantification of intestinal inflammation in the the setting of pediatric small bowel Crohns disease

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Ultrasound Microbubble Contrast Agent	–	Drug: Ultrasound Microbubble Contrast Agent, Device: Ultrasound ImagingAll subjects will receive intravenous Lumason microbubble contrast agent; there is no comparative ultrasound contrast agent. Contrast Enhanced Ultrasound findings/results will be correlated with comparable, clinically performed, CTE/MRE findings/results

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: We plan to recruit approximately 25 subjects, 10-18 years of age, with known small bowel Crohn disease undergoing clinically indicated Computed Tomography Enterography (CTE) or Magnetic Resonance Enterography (MRE)imaging

Key inclusion criteria (3 listed)

histologic evidence of small bowel Crohn's disease, or clinical evidence of disease (including radiologic confirmation [either CT or MRI] and receiving medical therapy for Crohn's disease).
Between ages 10 and 18 years.
Undergoing clinically-indicated CTE or MRE with evidence of active disease based on pediatric gastroenterologist clinical assessment

Key exclusion criteria (6 listed)

Patients under the age of 10 or over the age of 18.
Pregnancy or breast feeding. Urine pregnancy testing will be performed on all female study participants of reproductive potential.
Obesity/body habitus preventing visualization of small bowel affected by Crohn's disease by ultrasound (Body mass index ≥30 kg/m2
Subject inability/unwillingness to consent or child assent, including severe developmental delay/mental retardation.
Prior allergic-like reaction or other severe adverse event to Lumason or any of the active ingredients in Lumason (SPECIFIC CONTRAINDICATION from Package Insert).

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
Ultrasound Microbubble Contrast AgentAlso: LumasonPatients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel	Drug	Ultrasound Microbubble Contrast Agent
Ultrasound ImagingPatients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel	Device	Ultrasound Microbubble Contrast Agent

Primary outcome

Degree of bowel wall enhancement
Time frame: 2 years
Percent hyperenhancement (compared to normal bowel loops)

3 secondary outcomes

Overall Disease Status for imaged section
Time frame: 2 years
Degree of mesenteric inflammation
Time frame: 2 years
Maximum Bowel Wall Thickness
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Background: PubMed 21710535Adler J, Punglia DR, Dillman JR, Polydorides AD, Dave M, Al-Hawary MM, Platt JF, McKenna BJ, Zimmermann EM. Computed tomography enterography findings correlate with tissue inflammation, not fibrosis in resected small bowel Crohn's disease. Inflamm Bowel Dis. 2012 May;18(5):849-56. doi: 10.1002/ibd.21801. Epub 2011 Jun 24.
Background: PubMed 20449794Girlich C, Jung EM, Huber E, Ott C, Iesalnieks I, Schreyer A, Schacherer D. Comparison between preoperative quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound and operative macroscopic findings and results of histopathological scoring in Crohn's disease. Ultraschall Med. 2011 Apr;32(2):154-9. doi: 10.1055/s-0029-1245398. Epub 2010 May 6.
Background: PubMed 19070446Quaia E, Migaleddu V, Baratella E, Pizzolato R, Rossi A, Grotto M, Cova MA. The diagnostic value of small bowel wall vascularity after sulfur hexafluoride-filled microbubble injection in patients with Crohn's disease. Correlation with the therapeutic effectiveness of specific anti-inflammatory treatment. Eur J Radiol. 2009 Mar;69(3):438-44. doi: 10.1016/j.ejrad.2008.10.029. Epub 2008 Dec 12.
Background: PubMed 21830051Wong DD, Forbes GM, Zelesco M, Mason R, Pawlik J, Mendelson RM. Crohn's disease activity: quantitative contrast-enhanced ultrasound assessment. Abdom Imaging. 2012 Jun;37(3):369-76. doi: 10.1007/s00261-011-9792-z.
Background: PubMed 22157203De Franco A, Di Veronica A, Armuzzi A, Roberto I, Marzo M, De Pascalis B, De Vitis I, Papa A, Bock E, Danza FM, Bonomo L, Guidi L. Ileal Crohn disease: mural microvascularity quantified with contrast-enhanced US correlates with disease activity. Radiology. 2012 Feb;262(2):680-8. doi: 10.1148/radiol.11110440. Epub 2011 Dec 12.
Background: PubMed 21439749Girlich C, Schacherer D, Jung EM, Schreyer A, Buttner R. Comparison between a clinical activity index (Harvey-Bradshaw-Index), laboratory inflammation markers and quantitative assessment of bowel wall vascularization by contrast-enhanced ultrasound in Crohn's disease. Eur J Radiol. 2012 Jun;81(6):1105-9. doi: 10.1016/j.ejrad.2011.02.054. Epub 2011 Mar 24.
Background: PubMed 19635834Ripolles T, Martinez MJ, Paredes JM, Blanc E, Flors L, Delgado F. Crohn disease: correlation of findings at contrast-enhanced US with severity at endoscopy. Radiology. 2009 Oct;253(1):241-8. doi: 10.1148/radiol.2531082269. Epub 2009 Jul 27.
Background: PubMed 22271005Malago R, D'Onofrio M, Mantovani W, D'Alpaos G, Foti G, Pezzato A, Caliari G, Cusumano D, Benini L, Pozzi Mucelli R. Contrast-enhanced ultrasonography (CEUS) vs. MRI of the small bowel in the evaluation of Crohn's disease activity. Radiol Med. 2012 Mar;117(2):268-81. doi: 10.1007/s11547-011-0783-5. Epub 2012 Jan 21.
Background: PubMed 22698508Quaia E, De Paoli L, Stocca T, Cabibbo B, Casagrande F, Cova MA. The value of small bowel wall contrast enhancement after sulfur hexafluoride-filled microbubble injection to differentiate inflammatory from fibrotic strictures in patients with Crohn's disease. Ultrasound Med Biol. 2012 Aug;38(8):1324-32. doi: 10.1016/j.ultrasmedbio.2012.04.008. Epub 2012 Jun 13.
Background: PubMed 21273775Schirin-Sokhan R, Winograd R, Tischendorf S, Wasmuth HE, Streetz K, Tacke F, Trautwein C, Tischendorf JJ. Assessment of inflammatory and fibrotic stenoses in patients with Crohn's disease using contrast-enhanced ultrasound and computerized algorithm: a pilot study. Digestion. 2011;83(4):263-8. doi: 10.1159/000321389. Epub 2011 Jan 28.
Background: PubMed 23001574Riccabona M, Avni FE, Damasio MB, Ording-Muller LS, Blickman JG, Darge K, Lobo ML, Papadopoulou F, Vivier PH, Willi U. ESPR Uroradiology Task Force and ESUR Paediatric Working Group--Imaging recommendations in paediatric uroradiology, part V: childhood cystic kidney disease, childhood renal transplantation and contrast-enhanced ultrasonography in children. Pediatr Radiol. 2012 Oct;42(10):1275-83. doi: 10.1007/s00247-012-2436-9. Epub 2012 Sep 22.
Background: PubMed 19064035Main ML, Ryan AC, Davis TE, Albano MP, Kusnetzky LL, Hibberd M. Acute mortality in hospitalized patients undergoing echocardiography with and without an ultrasound contrast agent (multicenter registry results in 4,300,966 consecutive patients). Am J Cardiol. 2008 Dec 15;102(12):1742-6. doi: 10.1016/j.amjcard.2008.08.019. Epub 2008 Oct 23.
Individual participant dataSharing planned: Yes. Research data including identifying information about participants will only be accessible to CCHMC study personnel. De-identified data including images will be shared with scientists at Bracco Diagnostics. No identifiable data will be shared

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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.

Jonathan Dillman, MD,MSc principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn Disease, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jun 2026. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Degree of bowel wall enhancement (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03492944, which also lists 15 linked publications.

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 2026.