Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Efficacy

To validate the use of 0.05 mmol/kg of Gadopiclenol in the detection and monitoring of perianal fistulas by magnetic resonance imaging studies.

Secondary objectives 1

1. To determine possible differences in magnetic resonance imaging studies using Gadopiclenol compared with conventional contrast media in patients with Crohn's disease and perianal fistulas.

Conditions and MedDRA coding

Perianal fistula associated with Crohn's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients of legal age with Crohn's disease and perianal disease attributable to their condition
2. Subjects with onset of Crohn's disease with perianal disease
3. Sign informed consent

Exclusion criteria 5

1. Age ˂18 years
2. Pregnancy and/or breastfeeding
3. Renal failure (GFR ˂30 ml/min in recent laboratory values up to 6 months old)
4. History of hypersensitivity reaction to gadolinium-containing contrast media
5. Patients with Crohn's disease without perianal disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.

Secondary endpoints 3

1. The secondary variables to be analyzed will enable a more exhaustive study of the use of contrast media in this type of pathology, in order to refine its use. The secondary variables are quantitative in nature and are as follows:
2. CNR (contrast-to-noise ratio) between different regions of interest in the fistulous tract and adjacent healthy tissue.
3. Enhancement contrast percentage in different regions of interest of the fistulous tract before and after contrast medium administration.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Sponsor organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Address

Passeig De La Vall D'Hebron 119-129

City

Barcelona

Postcode

08035

Country

Spain

Scientific contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Angélica Valderrama Rodríguez

Public contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Angélica Valderrama Rodríguez

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications