Multimodal Ultrasound in Inflammatory Bowel Diseases (CELESTIAL)
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Multimodal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Fondazione Policlinico Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
patients with Crohn's disease or Ulcerative Colitis needing to begin biologic treatment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
predicting treatment response
to quantify the other D-CEUS parameters (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)
predicting treatment response
to quantify mean intestinal loop stiffness (measured by shear wave elastography) in patients with inflammatory bowel diseases undergoing biological treatment, stratified according to 12-months response to treatment (responders vs non-responders)
Full Information
NCT ID
NCT05987501
First Posted
March 16, 2023
Last Updated
August 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05987501
Brief Title
Multimodal Ultrasound in Inflammatory Bowel Diseases
Acronym
CELESTIAL
Official Title
Prospective Study to Evaluate the Role of Contrast-enhanced Ultrasound (CEUS) and Elastography in Predicting Clinical and Endoscopic Remission (Deep Remission) in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Background: Clinical remission is no more considered an appropriate therapeutic target for Inflammatory Bowel Diseases (IBD) and other parameters such as endoscopic and transmural remission are now recognized as prognostic factors ("deep remission"). Correctly monitoring treatment response is crucial to rapidly adequate therapeutic algorithms avoiding complications. 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.
Primary objective: to evaluate the role of D-CEUS and SWE in predicting deep remission at 12 months from treatment induction in IBD.
Secondary objectives:
To evaluate the relationship between clinical activity and CEUS/elastography parameters
To evaluate the relationship between endoscopic activity and CEUS/elastography parameters
To evaluate the relationship between inflammation indices and CEUS/elastography
Exploratory aims:
To evaluate the relationship between CEUS/elastography parameters and serum biomarkers of fibrosis
To evaluate the relationship between CEUS/elastography parameters and faecal microbiota in a subset of patients Study design: Prospective, interventional, single-center study. Methods: 50 consecutive patients with Crohn's disease or Ulcerative Colitis needing to begin biologic treatment according to international guidelines and with an affected intestinal segment detectable in B-mode ultrasound will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. Exclusion criteria will be 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 and lactation. Colonoscopies, blood tests and ultrasound evaluations (B-mode ultrasound, elastography and CEUS) will be performed as per normal clinical practice. Data obtained from these procedures will be recorded and analyzed specifically for the study. The only study-specific procedures are the collection of fecal samples for microbiota evaluation, urine samples for metabolomics evaluation and an additional blood sample for evaluation of fibrosis biomarkers, both collected at the time of recruitment. The additional blood sample will be taken from the same peripheral venous access route used for blood sampling in normal clinical practice. Ileal elastography and CEUS will be performed before starting treatment and after 2/3, 8 and 16 weeks, 6 months, 12 months, 24 months and 36 months. If indicated by clinical assessment, some patients will be re-evaluated after 3 weeks. Clinical assessment will include Harvey-Bradshaw index or Mayo score, blood cell count, CRP and ESR, as per clinical practice. An additional blood sampling will be done for fibrosis biomarker evaluation. In particular, we will do multiple analysis (Bio-Plex, Biorad ) for IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17, Eotaxin, basic FGF, G-CSF, GM-CSF, IFN-g, IP-10, MCP-1, MIP-1a, PDGF-bb, MIP-1b, RANTES, TNF-a, VEGF, TL -1a, TGF-b, IL-33, ST2. Data about the clinical outcome (i.e. surgery, hospitalizations, need for steroids…) and biomarkers of fibrosis will be collected up to 36 months after the start of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
patients with Crohn's disease or Ulcerative Colitis needing to begin biologic treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
Multimodal ultrasound
Intervention Description
Contrast enhanced ultrasound and shear wave elastography on target intestinal loop are perfomed before and at different timepoints after treatment induction
Primary Outcome Measure Information:
Title
predicting treatment response
Description
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)
Time Frame
12 months after treatment induction
Secondary Outcome Measure Information:
Title
predicting treatment response
Description
to quantify the other D-CEUS parameters (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)
Time Frame
12 months after treatment induction
Title
predicting treatment response
Description
to quantify mean intestinal loop stiffness (measured by shear wave elastography) in patients with inflammatory bowel diseases undergoing biological treatment, stratified according to 12-months response to treatment (responders vs non-responders)
Time Frame
12 months after treatment induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Assunta Zocco
Phone
00393470597805
Email
mariaassunta.zocco@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA ASSUNTA ZOCCO, PhD
Phone
00393470597805
12. IPD Sharing Statement
Learn more about this trial
Multimodal Ultrasound in Inflammatory Bowel Diseases
We'll reach out to this number within 24 hrs