Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Browse trials for

• Crohn Disease 1,880
• Intestinal Diseases 963
• Inflammatory Bowel Diseases 1,460

Keywords

• Fluorescence Molecular Endoscopy
• Inflammatory Bowel Disease
• Adalimumab-680LT

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 21 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Study arms

• Other
  No administration of adalimumab-680LT

  Patients did not receive adalimumab-680LT, but underwent a Fluorescence Molecular Imaging procedure to serve as a control group and compare results with patients receiving the tracer

  Other: Control

• Experimental
  4.5 mg adalimumab-680LT

  Patients received 4.5 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

  Drug: Adalimumab-680LT

• Experimental
  15 mg adalimumab-680LT

  Patients received 15 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

  Drug: Adalimumab-680LT

• Experimental
  25 mg adalimumab-680LT

  Patients received 25 mg adalimumab-680LT and underwent a Fluorescence Molecular Imaging procedure

  Drug: Adalimumab-680LT

• Experimental
  >14 weeks of adalimumab therapy + optimal dose adalimumab-680LT

  Patients who received the optimal dose during the first Fluorescence Molecular Imaging procedure are invited for a second procedure after at least 14 weeks of adalimumab therapy. They will receive the optimal dose adalimumab-680LT and will undergo another Fluorescence Molecular Imaging procedure

  Drug: Adalimumab-680LT

Interventions

• DrugAdalimumab-680LT

  First, adalimumab-680LT was administered intravenously. 2-3 days later, a Fluorescence Molecular Imaging procedure was performed to enable the visualisation and detection of fluorescence signals.

• OtherControl

  Fluorescence Molecular Imaging was performed to enable the visualisation and detection of fluorescence signals.

Primary outcomes

1. Determine the safety of adalimumab-680LT in IBD

   Evaluating possible (severe) adverse events (SAE \& AEs)

   Time frame: Until 24 hours after administration

2. Blood pressure

   Millimeters of mercure (mmHg)

   Time frame: Five minutes before, and five and sixty minutes after tracer administration

3. Heart rate

   Beats per minute

   Time frame: Five minutes before, and five and sixty minutes after tracer administration

4. Temperature

   Degrees Celsius

   Time frame: Five minutes before, and five and sixty minutes after tracer administration

5. Investigate the feasibility of using FME to detect adalimumab-680LT signals

   Evaluating the performance of FME for detecting adalimumab-680LT signals. This evaluation will be based on a visual evaluation during FME (visible signal yes/no), TBR and CNR calculations and MDSFR/SFF measurements.

   Time frame: 12 months

6. Investigate the feasibility of using ex vivo FMI to detect adalimumab-680LT

   Evaluating the performance of ex vivo FMI for detecting adalimumab-680LT signals. This evaluation will be based on mean fluorescence intensities (MFIs) of biopsies and fluorescence/light sheet microscopy.

   Time frame: 12 months

7. Determining the optimal imaging dose of adalimumab-680LT

   The optimal dose will be based on the adalimumab-680LT signals during FME and ex vivo FMI

   Time frame: 12 months

Secondary outcomes

1. Investigate a potential correlation of in vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab therapy regimen in patients with IBD

   Evaluation of the potential correlation in vivo will be based on in vivo fluorescence images and the MDSFR/SFF measurements before and after at least 14 weeks of adalimumab treatment

   Time frame: 12 months

2. Investigate a potential correlation of ex vivo fluorescence signal intensities and target saturation to clinical response/remission after 14 weeks of adalimumab therapy regimen in patients with IBD

   Evaluation of the potential correlation ex vivo will be based on MFIs of biopsies, fluorescence microscopy results, and tracer concentrations inside biopsies before and after at least 14 weeks of adalimumab treatment

   Time frame: 12 months

3. Quantify the fluorescence signals of the tracer in vivo by using single-fiber reflectance/single-fiber fluorescence (MDSFR/SFF) spectroscopy and correlate these measurements to tracer dose, in vivo fluorescence intensities and inflammation severity

   Quantification of MDSFR/SFF measurements in inflamed tissue compared to measurements in non-inflamed tissue. Positive correlation between MDSFR/SFF measurements and dose/inflammation severity?

   Time frame: 12 months

4. To correlate ex vivo fluorescence signals to inflammation severity and tracer dose based on histopathological examination inside the obtained biopsies

   Histologically ascertained tissue types (qualitative): Normal (non-inflamed) ileal, colon and rectal tissue Inflamed ileum, colon and rectum tissue Random ''high-fluorescent'' tissue Random ''Non-fluorescent'' tissue

   Time frame: 12 months

5. To assess tracer stability, tracer distribution and tracer concentration, and to identify the composition of immune cells ex vivo to learn more about adalimumab mucosal target cells

   Fluorescence (confocal) microscopy with additional use of immune panels and spatial transcriptomics analysis (before and after at least 14 weeks of adalimumab treatment). Measurements of the adalimumab-680LT concentration by light-sheet microscopy after tissue clearing, insights in adalimumab-target cells and presence of immune cells inside the biopsies and blood samples by flow cytometry and assessment of tracer stability by Western Blot

   Time frame: 12 months

Individual participant data

Plan to share: No