A prospective Pilot Intervention Study: Near-infrared fluorescence molecular endoscopy for elucidating the mechanism of action and predicting response to vedolizumab in IBD using labelled vedoLizumab-8000CW.

A prospective Pilot Intervention Study: Near-infrared fluorescence molecular endoscopy for elucidating the mechanism of action and predicting response to vedolizumab in IBD using labelled vedoLizumab-8000CW. - NIR-FME with vedolizumab-800CW in IBD. VISION study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54932

Enrollment

Registered

2019-06-04

Start date

2020-02-24

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

Patients will be, 2 to 4 days prior to the endoscopic procedure, intravenously administrerd with the tracer vedolizumab-800CW. Where after fluorescence endocopy, MDSFR/SFF spectroscopy and confocale

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn*s Disease (CD). • Severely affected and therefore a candidate for vedolizumab treatment or already treated with vedolizumab. • Age: 18 years or older. • Written informed consent.

Exclusion criteria

Exclusion criteria: • Patients younger than 18 years old • Prior vedolizumab treatment • Pregnancy or breast feeding. * For therapy arm vedolizumab treatment is no exclusion criterium

Design outcomes

Primary

Measure	Time frame
• Quantification of fluorescent signal after a microdose of vedolizumab-800CW in inflamed and non-inflamed tissue in patients with IBD. • Correlation between the fluorescent signal and the clinical response and remission to regular vedolizumab treatment in individual patients with IBD. • Correlation with response and remission to vedolizumab treatment and the composition of immune cells in the mucosal microenvironment. • Correlation with response and remission to vedolizumab treatment and the composition of immune cells in the peripheral blood compartment. • The safety of vedolizumab-800CW through monitoring vital signs, the injection site and evaluating possible tracer-related (severe) adverse events (SAE/AEs).	—

Measure

Time frame

• Quantification of fluorescent signal after a microdose of vedolizumab-800CW in inflamed and non-inflamed tissue in patients with IBD. • Correlation between the fluorescent signal and the clinical response and remission to regular vedolizumab treatment in individual patients with IBD. • Correlation with response and remission to vedolizumab treatment and the composition of immune cells in the mucosal microenvironment. • Correlation with response and remission to vedolizumab treatment and the composition of immune cells in the peripheral blood compartment. • The safety of vedolizumab-800CW through monitoring vital signs, the injection site and evaluating possible tracer-related (severe) adverse events (SAE/AEs).

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Secondary

Measure	Time frame
• Difference in vivo and ex vivo fluorescent signal between inflamed and non-inflamed tissue • Identification of vedolizumab target cells (innate vs. lymphocytes) in both inflamed and non-inflamed tissue. • Gain insight in target engagement in patients treated with vedolizumab therapy for at least 14 weeks. • Investigate autofluorescence signals in normal and inflamed tissue by including patients without tracer administration. Response to treatment: - Clincal response to vedolizumab treatment using worldwide approved clinical scoring methods, (SCCAI for UC and HBI for CD). Clinical induction response is defined when patients reached halved the clinical score at week 14 compared to week 0 due to vedolizumab treatment. - Biochemical response to vedolizumab treatment is defined when people reached normalization of C-reactive protein and leukocytes thanks to vedolizumab. - Endoscopic response to vedolizumab treatment is defined when patients have a reduction of endoscopic disease activity using the worldwide approved scoring method: MAYO for UC and SES-CD score for CD. - The correlation between responders versus non responders compared with fluorescence intensity to predict response to treatment. - Elucidate the differences between vedolizumab distribution between CD and UC.	—

Measure

Time frame

• Difference in vivo and ex vivo fluorescent signal between inflamed and non-inflamed tissue • Identification of vedolizumab target cells (innate vs. lymphocytes) in both inflamed and non-inflamed tissue. • Gain insight in target engagement in patients treated with vedolizumab therapy for at least 14 weeks. • Investigate autofluorescence signals in normal and inflamed tissue by including patients without tracer administration. Response to treatment: - Clincal response to vedolizumab treatment using worldwide approved clinical scoring methods, (SCCAI for UC and HBI for CD). Clinical induction response is defined when patients reached halved the clinical score at week 14 compared to week 0 due to vedolizumab treatment. - Biochemical response to vedolizumab treatment is defined when people reached normalization of C-reactive protein and leukocytes thanks to vedolizumab. - Endoscopic response to vedolizumab treatment is defined when patients have a reduction of endoscopic disease activity using the worldwide approved scoring method: MAYO for UC and SES-CD score for CD. - The correlation between responders versus non responders compared with fluorescence intensity to predict response to treatment. - Elucidate the differences between vedolizumab distribution between CD and UC.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)