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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04112212
Date of registration: 25/09/2019
Prospective Registration: Yes
Primary sponsor: University Medical Center Groningen
Public title: NIR FME of Labelled Vedolizumab to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. VISION
Scientific title: Near-infrared Fluorescence Molecular Endoscopy Imaging of Labelled Vedolizumab-800CW to Elucidate the Mechanism of Action and Predicting Response in IBD Patients. A Prospective Pilot Intervention Study:
Date of first enrolment: November 4, 2020
Target sample size: 35
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04112212
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Netherlands
Contacts
Name:     W B Nagengast, MD, PhD, PharmD
Address: 
Telephone: +31503612620
Email: w.b.nagengast@umcg.nl
Affiliation: 
Name:     W.B. Nagengast, MD, PhD, PharmD
Address: 
Telephone: +31503612620
Email: w.b.nagengast@umcg.nl
Affiliation: 
Name:     W.B. Nagengast, MD, PhD, PharmD
Address: 
Telephone:
Email:
Affiliation:  University Medical Center Groningen
Key inclusion & exclusion criteria

Inclusion Criteria:

- Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn's Disease (CD).

- Vedolizumab naïve and eligible for vedolizumab treatment.

- Age: 18 years or older.

- Written informed consent.

Exclusion Criteria:

- Prior vedolizumab treatment

- Vedolizumab contraindicated as therapy

- Pregnancy or breast feeding.

- Patients younger than 18 years old



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn Disease
Intervention(s)
Device: Fluorescence endoscopy and spectroscopy
Drug: Vedolizumab-800CW
Primary Outcome(s)
Fluorescent signal in patients with IBD [Time Frame: After 18 months when study is completed.]
Secondary Outcome(s)
Distribution of Vedolizumab in the inflamed gut [Time Frame: After 18 months when study is completed.]
Elucidate vedolizumab target cells [Time Frame: After 18 months when study is completed.]
FME Ex Vivo analysis to detect target cells [Time Frame: After 18 months when study is completed.]
Quantifying fluorescent signals in patients with IBD [Time Frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.]
Safety of Vedolizumab-800CW in patients with IBD [Time Frame: Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.]
Secondary ID(s)
NL69572.042.19
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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