Trauma AbdomenPhase 4NCT03490929
CEUS for Blunt Abdominal Trauma in Children
A Phase 4 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] and contrast-enhanced ultrasound in people with Trauma Abdomen, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial summary
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Trauma Abdomen
- What is being tested?
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] and contrast-enhanced ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
- History of or suspicion for blunt abdominal trauma
- Abdominal CT ordered or obtained
Who cannot join
- History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
- Co-existing penetrating abdominal trauma
- Known congenital or acquired heart disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Aaron E Chen, MD, 267-426-0383, CHENA2@chop.edu
Tobias Kummer, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Tobias Kummer, MD, 507-255-4732, kummer.tobias@mayo.edu
Derek Vanmeter, 5072554732, VanMeter.Derek@mayo.edu
About this study
Official title: Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.
Read the detailed description
In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma
Design:
This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.
- Conditions
- Trauma Abdomen
- Being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON], contrast-enhanced ultrasound
- Medical subject headings
- Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]Drug
Also called Lumason
injection of Lumason (ultrasound contrast agent)
contrast-enhanced ultrasoundDevice
Also called ultrasound
ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced ultrasound arm | Experimental | contrast-enhanced ultrasound Receives: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]; Device: contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CEUS
calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT
Measured: through study completion, which is expected to take around 3 years
Specificity of CEUS
calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam
Measured: through study completion, which is expected to take around 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Trauma AbdomenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Aaron E. Chen, Children's Hospital of Philadelphia
- Investigators
- Aaron E Chen, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490929
- Sponsor's protocol ID
- 18-014905
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2018
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Armstrong LB, Mooney DP, Paltiel H, Barnewolt C, Dionigi B, Arbuthnot M, Onwubiko C, Connolly SA, Jarrett DY, Zalieckas JM. Contrast enhanced ultrasound for the evaluation of blunt pediatric abdominal trauma. J Pediatr Surg. 2018 Mar;53(3):548-552. doi: 10.1016/j.jpedsurg.2017.03.042. Epub 2017 Mar 20.
PubMed 28351519Miele V, Piccolo CL, Galluzzo M, Ianniello S, Sessa B, Trinci M. Contrast-enhanced ultrasound (CEUS) in blunt abdominal trauma. Br J Radiol. 2016;89(1061):20150823. doi: 10.1259/bjr.20150823. Epub 2016 Jan 8.
PubMed 26607647Menichini G, Sessa B, Trinci M, Galluzzo M, Miele V. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic solid organ lesions in children: a retrospective comparison with baseline US and CE-MDCT. Radiol Med. 2015 Nov;120(11):989-1001. doi: 10.1007/s11547-015-0535-z. Epub 2015 Mar 31.
PubMed 25822953Cagini L, Gravante S, Malaspina CM, Cesarano E, Giganti M, Rebonato A, Fonio P, Scialpi M. Contrast enhanced ultrasound (CEUS) in blunt abdominal trauma. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S9. doi: 10.1186/2036-7902-5-S1-S9. Epub 2013 Jul 15.
PubMed 23902930Cokkinos D, Antypa E, Stefanidis K, Tserotas P, Kostaras V, Parlamenti A, Tavernaraki K, Piperopoulos PN. Contrast-enhanced ultrasound for imaging blunt abdominal trauma - indications, description of the technique and imaging review. Ultraschall Med. 2012 Feb;33(1):60-7. doi: 10.1055/s-0031-1273442. Epub 2012 Jan 24.
PubMed 22274907Afaq A, Harvey C, Aldin Z, Leen E, Cosgrove D. Contrast-enhanced ultrasound in abdominal trauma. Eur J Emerg Med. 2012 Jun;19(3):140-5. doi: 10.1097/MEJ.0b013e328348c980.
PubMed 21934507Valentino M, De Luca C, Galloni SS, Branchini M, Modolon C, Pavlica P, Barozzi L. Contrast-enhanced US evaluation in patients with blunt abdominal trauma(). J Ultrasound. 2010 Mar;13(1):22-7. doi: 10.1016/j.jus.2010.06.002. Epub 2010 Jul 8.
PubMed 23396012Valentino M, Ansaloni L, Catena F, Pavlica P, Pinna AD, Barozzi L. Contrast-enhanced ultrasonography in blunt abdominal trauma: considerations after 5 years of experience. Radiol Med. 2009 Oct;114(7):1080-93. doi: 10.1007/s11547-009-0444-0. Epub 2009 Sep 22.
PubMed 19774445Sivit CJ. Imaging children with abdominal trauma. AJR Am J Roentgenol. 2009 May;192(5):1179-89. doi: 10.2214/AJR.08.2163.
PubMed 19380540Catalano O, Aiani L, Barozzi L, Bokor D, De Marchi A, Faletti C, Maggioni F, Montanari N, Orlandi PE, Siani A, Sidhu PS, Thompson PK, Valentino M, Ziosi A, Martegani A. CEUS in abdominal trauma: multi-center study. Abdom Imaging. 2009 Mar-Apr;34(2):225-34. doi: 10.1007/s00261-008-9452-0.
PubMed 18682877Clevert DA, Weckbach S, Minaifar N, Clevert DA, Stickel M, Reiser M. Contrast-enhanced ultrasound versus MS-CT in blunt abdominal trauma. Clin Hemorheol Microcirc. 2008;39(1-4):155-69.
PubMed 18503121Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.
PubMed 18195385Bixby SD, Callahan MJ, Taylor GA. Imaging in pediatric blunt abdominal trauma. Semin Roentgenol. 2008 Jan;43(1):72-82. doi: 10.1053/j.ro.2007.08.009. No abstract available.
PubMed 18053830Ntoulia A, Anupindi SA, Darge K, Back SJ. Applications of contrast-enhanced ultrasound in the pediatric abdomen. Abdom Radiol (NY). 2018 Apr;43(4):948-959. doi: 10.1007/s00261-017-1315-0.
PubMed 28980061Darge K, Papadopoulou F, Ntoulia A, Bulas DI, Coley BD, Fordham LA, Paltiel HJ, McCarville B, Volberg FM, Cosgrove DO, Goldberg BB, Wilson SR, Feinstein SB. Safety of contrast-enhanced ultrasound in children for non-cardiac applications: a review by the Society for Pediatric Radiology (SPR) and the International Contrast Ultrasound Society (ICUS). Pediatr Radiol. 2013 Sep;43(9):1063-73. doi: 10.1007/s00247-013-2746-6. Epub 2013 Jul 11.
PubMed 23843130
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
- ClinicalTrials.gov ID
- NCT03490929
- Acronym / sponsor ID
- 18-014905
- Conditions
- Trauma Abdomen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 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.
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.
Detailed description
In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma
Design:
This will be a prospective cohort study to evaluate the test characteristics of contrast enhanced ultrasound (CEUS) for the detection of intra-abdominal solid organ injury in children with blunt abdominal trauma, as compared to a gold standard CT scan. Study subjects will be age 0-18 years, presenting with hemodynamically stable blunt abdominal trauma and for whom an abdominal CT scan is planned. The exclusion criteria will be a known allergy to the ultrasound contrast agent, co-existing penetrating abdominal trauma, or known congenital or acquired heart disease. Sample size calculations assume a baseline prevalence of disease in approximately 20% of patients receiving a CT scan, and target a sensitivity of at least 95% with a two-sided confidence interval precision of 8%, yielding an estimated sample size of 146 patients. The primary outcome will be calculation of sensitivity and specificity of CEUS as compared to a gold standard CT scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced ultrasound arm | Experimental | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON], Device: contrast-enhanced ultrasoundcontrast-enhanced ultrasound |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
- History of or suspicion for blunt abdominal trauma
- Abdominal CT ordered or obtained
Key exclusion criteria (3 listed)
- History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
- Co-existing penetrating abdominal trauma
- Known congenital or acquired heart disease
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 |
|---|---|---|
| Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]Also: Lumasoninjection of Lumason (ultrasound contrast agent) | Drug | Contrast-enhanced ultrasound arm |
| contrast-enhanced ultrasoundAlso: ultrasoundultrasound of the abdomen after injection of ultrasound contrast agent (Lumason) | Device | Contrast-enhanced ultrasound arm |
Primary outcome
Sensitivity of CEUS
Time frame: through study completion, which is expected to take around 3 years
calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT
Specificity of CEUS
Time frame: through study completion, which is expected to take around 3 years
calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 28351519Armstrong LB, Mooney DP, Paltiel H, Barnewolt C, Dionigi B, Arbuthnot M, Onwubiko C, Connolly SA, Jarrett DY, Zalieckas JM. Contrast enhanced ultrasound for the evaluation of blunt pediatric abdominal trauma. J Pediatr Surg. 2018 Mar;53(3):548-552. doi: 10.1016/j.jpedsurg.2017.03.042. Epub 2017 Mar 20.
- Background: PubMed 26607647Miele V, Piccolo CL, Galluzzo M, Ianniello S, Sessa B, Trinci M. Contrast-enhanced ultrasound (CEUS) in blunt abdominal trauma. Br J Radiol. 2016;89(1061):20150823. doi: 10.1259/bjr.20150823. Epub 2016 Jan 8.
- Background: PubMed 25822953Menichini G, Sessa B, Trinci M, Galluzzo M, Miele V. Accuracy of contrast-enhanced ultrasound (CEUS) in the identification and characterization of traumatic solid organ lesions in children: a retrospective comparison with baseline US and CE-MDCT. Radiol Med. 2015 Nov;120(11):989-1001. doi: 10.1007/s11547-015-0535-z. Epub 2015 Mar 31.
- Background: PubMed 23902930Cagini L, Gravante S, Malaspina CM, Cesarano E, Giganti M, Rebonato A, Fonio P, Scialpi M. Contrast enhanced ultrasound (CEUS) in blunt abdominal trauma. Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S9. doi: 10.1186/2036-7902-5-S1-S9. Epub 2013 Jul 15.
- Background: PubMed 22274907Cokkinos D, Antypa E, Stefanidis K, Tserotas P, Kostaras V, Parlamenti A, Tavernaraki K, Piperopoulos PN. Contrast-enhanced ultrasound for imaging blunt abdominal trauma - indications, description of the technique and imaging review. Ultraschall Med. 2012 Feb;33(1):60-7. doi: 10.1055/s-0031-1273442. Epub 2012 Jan 24.
- Background: PubMed 21934507Afaq A, Harvey C, Aldin Z, Leen E, Cosgrove D. Contrast-enhanced ultrasound in abdominal trauma. Eur J Emerg Med. 2012 Jun;19(3):140-5. doi: 10.1097/MEJ.0b013e328348c980.
- Background: PubMed 23396012Valentino M, De Luca C, Galloni SS, Branchini M, Modolon C, Pavlica P, Barozzi L. Contrast-enhanced US evaluation in patients with blunt abdominal trauma(). J Ultrasound. 2010 Mar;13(1):22-7. doi: 10.1016/j.jus.2010.06.002. Epub 2010 Jul 8.
- Background: PubMed 19774445Valentino M, Ansaloni L, Catena F, Pavlica P, Pinna AD, Barozzi L. Contrast-enhanced ultrasonography in blunt abdominal trauma: considerations after 5 years of experience. Radiol Med. 2009 Oct;114(7):1080-93. doi: 10.1007/s11547-009-0444-0. Epub 2009 Sep 22.
- Background: PubMed 19380540Sivit CJ. Imaging children with abdominal trauma. AJR Am J Roentgenol. 2009 May;192(5):1179-89. doi: 10.2214/AJR.08.2163.
- Background: PubMed 18682877Catalano O, Aiani L, Barozzi L, Bokor D, De Marchi A, Faletti C, Maggioni F, Montanari N, Orlandi PE, Siani A, Sidhu PS, Thompson PK, Valentino M, Ziosi A, Martegani A. CEUS in abdominal trauma: multi-center study. Abdom Imaging. 2009 Mar-Apr;34(2):225-34. doi: 10.1007/s00261-008-9452-0.
- Background: PubMed 18503121Clevert DA, Weckbach S, Minaifar N, Clevert DA, Stickel M, Reiser M. Contrast-enhanced ultrasound versus MS-CT in blunt abdominal trauma. Clin Hemorheol Microcirc. 2008;39(1-4):155-69.
- Background: PubMed 18195385Valentino M, Serra C, Pavlica P, Labate AM, Lima M, Baroncini S, Barozzi L. Blunt abdominal trauma: diagnostic performance of contrast-enhanced US in children--initial experience. Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.
- Individual participant dataSharing planned: Undecided
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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.
Aaron E Chen, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] and contrast-enhanced ultrasound in people with Trauma Abdomen, run by Children's Hospital of Philadelphia at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron E Chen, MD (2674260383, chena2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CEUS (time frame: through study completion, which is expected to take around 3 years). The study lists 2 primary outcomes in all. 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 NCT03490929, which also lists 16 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 17 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.