perianal Crohn's fistula
Conditions
Brief summary
- Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points
Detailed description
- The best fitting kinetic model to quantify 68Ga-FAPi-46 pharmacokinetics and tracer uptake., - The most suitable simplified quantitative measurement as a surrogate for the full kinetic model., - The most simplified imaging procedure providing the quantitative measurement correlating to the full kinetic model., - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (week 2 or week 6 or combined) and the change over both time points with clinical and/or radiological response assessments mid- and end-of-treatment (i.e. week 9 and week 26, respectively)., - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline with clinical and MRI (and eventual endoscopy and pathology if available) parameters at baseline.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points | — |
Secondary
| Measure | Time frame |
|---|---|
| - The best fitting kinetic model to quantify 68Ga-FAPi-46 pharmacokinetics and tracer uptake., - The most suitable simplified quantitative measurement as a surrogate for the full kinetic model., - The most simplified imaging procedure providing the quantitative measurement correlating to the full kinetic model., - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (week 2 or week 6 or combined) and the change over both time points with clinical and/or radiological response assessments mid- and end-of-treatment (i.e. week 9 and week 26, respectively)., - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline with clinical and MRI (and eventual endoscopy and pathology if available) parameters at baseline. | — |
Countries
Netherlands