NCT05987501

Brief Summary

The role of intestinal ultrasound in treatment monitoring has recently gained increasing interest thanks to its non-invasiveness, cost-effectiveness and largely availability. Moreover, new ultrasonographic tools, particularly dynamic contrast-enhanced ultrasound (D-CEUS) and shear wave elastography (SWE) can provide further useful information, such as a quantitative estimation of bowel intramural microvacularization and tissue stiffness. Aim of this study is to evaluate the role of D-CEUS and SWE in predicting deep remission at 12 months from treatment induction in IBD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

4.5 years

First QC Date

March 16, 2023

Last Update Submit

August 3, 2023

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • predicting treatment response

    to quantify peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients with inflammatory bowel diseases undergoing biological treatment, stratified according to 12-months response to treatment (responders vs non-responders)

    12 months after treatment induction

Secondary Outcomes (2)

  • predicting treatment response

    12 months after treatment induction

  • predicting treatment response

    12 months after treatment induction

Study Arms (1)

Patients

EXPERIMENTAL

patients with Crohn's disease or Ulcerative Colitis needing to begin biologic treatment

Diagnostic Test: Multimodal ultrasound

Interventions

Multimodal ultrasoundDIAGNOSTIC_TEST

Contrast enhanced ultrasound and shear wave elastography on target intestinal loop are perfomed before and at different timepoints after treatment induction

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • diagnosis of Crohn's disease or Ulcerative Colitis
  • indication to start biologic treatment according to international guidelines
  • affected intestinal segment detectable in B-mode ultrasound

You may not qualify if:

  • induction of biologic therapy in prophylaxis after surgery in Crohn's disease
  • lack of visualization of affected intestinal tract (eg. obesity)
  • diagnosis of undetermined colitis
  • hearth failure
  • known allergy to ultrasound contrast agents
  • pregnancy
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (1)

  • Ainora ME, Liguori A, Mignini I, Cintoni M, Galasso L, Laterza L, Lopetuso LR, Garcovich M, Riccardi L, Gasbarrini A, Scaldaferri F, Zocco MA. Multimodal dynamic ultrasound approach as predictor of response in patients with Crohn's disease treated with ustekinumab. Therap Adv Gastroenterol. 2024 Jun 22;17:17562848241259289. doi: 10.1177/17562848241259289. eCollection 2024.

    PMID: 38912296DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805mariaassunta.zocco@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 16, 2023

First Posted

August 14, 2023

Study Start

December 1, 2019

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

IT(1)