Topics

Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent

2020-03-29 04:04:43 | BioPortfolio

Summary

The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial.

Male and female subjects with a diagnosis of Crohn´s Disease and a clinical indication for an MRE examination, who are at least 18 years of age and who provide a written informed consent, will be eligible for inclusion.

The trial period will be up to 16 weeks and consists of 7 visits (see schedule of events). All patients who have attended at least 1 of the Magnetic Resonance Enterography (MRE)/Computerised Tomography Enterography (CTE) examinations should go through the end of treatment procedures at visit 7.

Subjects will attend two examinations during the course of the trial:

- A CTE

- An MRE The Crohn's disease activity will be assessed radiologically on the MRE and CTE scans by identifying the presence and severity of a number of morphologic entities and dynamic signs in the SB and colon as described in the RCDAS.

Additional evaluation of CD activity and disease complication on the MRE and CTE images will be performed using the CDMRIS scale and Lémann Index respectively

Description

The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial.

Patient recruitment will take place at 1 or more study centres by clinicians specialised in gastroenterology. MRE and CTE examinations will be performed at the department of Radiology at a hospital or private practise that performs radiology. Participating radiology department or private practice need to be certified to perform the examination at Skåne University Hospital, SUS, Malmö, Sweden.

Male and female subjects with a diagnosis of CD and a clinical indication for an MRE examination, who are at least 18 years of age and who provide a written informed consent, will be eligible for inclusion.

The trial period will be up to 16 weeks and consists of 7 visits (see schedule of events). All patients who have attended at least 1 of the MRE/CTE examinations should go through the end of treatment procedures at visit 7.

Subjects interested in participating in the trial will be screened for eligibility at visit 1. After receiving information about the trial according to the procedures for subject information and consent (see section 14.3) and found eligible according to the in-/exclusion criteria, patients will be included in the trial and randomised. After randomisation, the subject's demography, medical history and concomitant illness and medical treatment will be noted

Subjects will attend two examinations during the course of the trial:

- A CTE

- An MRE The order in which the MRE and CTE-L is performed will be randomised. Date and time for the patient's MRE examination will be booked at the department of radiology when the subject have been randomised. The date of CTE examination will then be booked two to three weeks apart from the MRE, either before or after according to the randomisation, to ensure both a proper washout period of given medical compounds and a minimal risk of change in status of the disease.

The Crohn's disease activity will be assessed radiologically on the MRE and CTE scans by identifying the presence and severity of a number of morphologic entities and dynamic signs in the SB and colon as described in the RCDAS.

The radiologist assessment, according to the RCDAS, of the CTE and MRE examinations will be performed by the investigators specialised in abdominal imaging at the department of radiology. The radiologist assessment of one patient's CTE and MRE examinations will not be performed by the same investigator in order to avoid that one assessment influence the other. Appointment of assessor for each examination will be performed by randomisation.

Pseudonymised assessment of CTE and MRE scans will be performed in batches of approximately 5 scans. Patient identification details will be removed from the scans and replaced by a code and the scans will be saved in a separate archive. The assessor will not have access to the code list.

After the completion of the trial, a blinded assessment of all pseudonymised images will be performed where the investigators assess the images initially assessed by the other investigator. The data will be used to document inter-reader variability.

Additional evaluation of CD activity and disease complication on the MRE and CTE images will be performed using the CDMRIS scale and Lémann Index respectively once all subjects have completed the trial. The CDMRIS scale and Lémann Index are described below. All assessments of the CTE and MRE images will be performed by the investigators at the department of radiology. Only the principal investigator will assess images according to Lémann and CDMRIS.

Other assessments:

During the time the subjects drink the contrast agent prior to the MRE/CTE scan, they will be asked to complete a questionnaire assessing taste, smell, consistency, fullness and ability to swallow the contrast agent.

The subjects will be contacted 2 days after the MRE and CTE examination for control of any potential AE and concomitant medication.

Subjects' experience of anxiety level at the CTE and MRE examinations will be investigated by the use of the State-Trait Anxiety Inventory for Adults questionnaires. The State questionnaire STAI-S consists of 20 statements that evaluate how respondents feel at the moment in terms of tension, apprehension, nervousness, and worry. The inventory might also be used to evaluate how respondents felt at a particular situation in the recent past. STAI-S has been found to be sensitive to changes in transitory anxiety. The Trait questionnaire STAI-T consist of 20 statements that evaluate how respondents feel in general and react to stressful situations. The subjects will respond to the STAI-S directly after the CTE, and MRE, as well as after optional capsule and ultrasound examinations respectively, when remaining at the clinic, and also to the STAI-T directly after the second radiology examination is performed.

A subset of up to 20 subjects will be asked to perform a capsule endoscopy examination and/or ultrasound examination.

- The capsule examination enables visualisation of both the small bowel and the colon mucosa in one procedure. The Crohn's disease severity and presence of strictures, ulcers and other lesions will be evaluated. In the small bowel and colon.

- The ultrasound examination enables visualisation of bowel wall thickening and flow and presence of ulcers, strictures, fistulas and abscesses.

Study Design

Conditions

Crohn Disease

Intervention

Lumentin, Movprep

Location

Department of medical imaging and function
Malmö
Sweden
20502

Status

Recruiting

Source

Lument AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-29T04:04:43-0400

Clinical Trials [654 Associated Clinical Trials listed on BioPortfolio]

A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44

Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast ...

Use of PET-CT in the Management of Crohn's Disease

Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depend...

Use of FDG PET/CT to Evaluate Crohn Disease

The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results o...

CP-461 for the Treatment of Crohn's Disease

Patients with moderately to severely active Crohn's disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks. The purpose of this study is to see if C...

Ovarian Reserve in Crohn's Disease

Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated...

PubMed Articles [14934 Associated PubMed Articles listed on BioPortfolio]

Small Bowel Adenocarcinoma: Is there a difference in survival for Crohn's versus Sporadic cases?

It is well known that Crohn's disease is a risk factor for the development of small bowel adenocarcinoma. However, the association between Crohn's disease-associated small bowel adenocarcinoma and sur...

MicroRNA23a Overexpression in Crohn's Disease Targets Tumour Necrosis Factor Alpha Inhibitor Protein 3, Increasing Sensitivity to TNF and Modifying the Epithelial Barrier.

Mucosal healing is important in Crohn's disease therapies. Epithelial homeostasis becomes dysregulated in Crohn's, with increased permeability, inflammation, and diarrhoea. MicroRNAs are small non-cod...

Diagnosis and outcome of oesophageal Crohn's disease.

Crohn's disease (CD) can involve any part of the gastrointestinal tract. We aimed to characterize clinical, endoscopic, histologic features and treatment outcomes of CD patients with oesophageal invol...

Successful treatment of hidradenitis suppurativa in the setting of Crohn disease with combination adalimumab and ustekinumab.

Herein we report the combination of adalimumab and ustekinumab to successfully treat a 39-year-old woman who presented for evaluation of hidradenitis suppurativa in the setting of Crohn disease of bot...

Causes and Prognosis of Intestinal Failure in Crohn's Disease: An 18-year Experience from a National Centre.

Intestinal failure (IF) is a feared complication of Crohn's disease (CD). Although cumulative loss of small bowel due to bowel resections is thought to be the dominant cause, the causes and outcomes h...

Medical and Biotech [MESH] Definitions

A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.

A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.

Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.

More From BioPortfolio on "Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent"

Quick Search

Relevant Topic

Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system.  Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...


Searches Linking to this Trial