NCT03652636 is a Phase 4 clinical trial of Sulfur Hexafluoride Microspheres in Hepatic Disease, sponsored by Indiana University.

Who is sponsoring NCT03652636?

NCT03652636 is sponsored by Indiana University.

What drugs are being tested in NCT03652636?

Interventions in NCT03652636: Sulfur Hexafluoride Microspheres.

What condition does NCT03652636 study?

NCT03652636 studies Hepatic Disease.

Is NCT03652636 still recruiting?

NCT03652636 is currently completed. Last updated 2 October 2024.

Are results published for NCT03652636?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-02 · How we verify

NCT03652636

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the Efficacy of Contrast Enhanced Ultrasound Compared to MRI for Differentiation of Hepatic Lesions

Completed Phase 4 Results posted Last updated 2 October 2024

What this trial tests

Phase 4 trial testing Sulfur Hexafluoride Microspheres in Hepatic Disease in 47 participants. Completed in 21 July 2023.

Timeline

5 August 2019

Primary endpoint
21 July 2023

21 July 2023

Quick facts

Lead sponsor	Indiana University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	47
Start date	5 August 2019
Primary completion	21 July 2023
Estimated completion	21 July 2023
Sites	1 location across United States

Drugs / interventions tested

Sulfur Hexafluoride Microspheres — full drug profile →

Conditions studied

Hepatic Disease — all drugs for Hepatic Disease →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Hepatic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of CEUS at Differentiating Focal Nodular Hyperplasia (FNH) From Hepatocellular Adenoma (HCA) Primary · One day

To compare the ability of contrast enhanced ultrasound to differentiate between hepatic adenoma and FNH compared with the current standard of contrast enhanced MRI.

Sensitivity (true positive rate)

Group	Value	95% CI
Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	66.7
Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	64.0

Specificity (true negative rate)

Group	Value	95% CI
Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	71.9
Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	90.6

Accuracy (is the ultrasound assessment of the lesion correct)

Group	Value	95% CI
Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	69.5
Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	78.0

AUC of Differentiating FNH From HCA (AUC Represents the Probability That the Model, if Given a Randomly Chosen Correct and Incorrect CEUS Diagnosis of a Lesion, Will Rank the Correct Higher Than the Incorrect) Secondary · One day

To compare the ability of contrast enhanced ultrasound to differentiate FNH from HCA

Group	Value	95% CI
Reader 1 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	0.693
Reader 2 - CEUS Sensitivity / Specificity Differentiating FNH & HCA	0.768

Sponsor's own description

In patients with hepatic lesions, to evaluate the efficacy of contrast enhanced ultrasound compared to MRI in differentiating focal nodular hyperplasia and hepatic adenoma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Contrast-Enhanced Ultrasound Compared With Hepatobiliary Agent MRI for Differentiation of Focal Nodular Hyperplasia and Hepatic Adenoma: A Prospective Trial.
Swensson J, McCrate M, Halappa VG, Stethen T, et al · · 2024 · cited 1× · PMID 39589314 · DOI 10.1097/ruq.0000000000000696

Verify or expand the search:

Other Indiana University trials

Trials by the same sponsor.

NCT07470086 — The Role of Environmental Temperatures in Respiratory Control · NA · not yet recruiting
NCT07470099 — The Role of Breathing Perception in Respiratory Control · NA · not yet recruiting
NCT07179952 — Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA ) · Phase 2 · not yet recruiting
NCT07070804 — Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03652636 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 2 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03652636.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing