Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05987501 |
| Other study ID # |
2743 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Maria Assunta Zocco |
| Phone |
00393470597805 |
| Email |
mariaassunta.zocco[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
