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FAPi-PET imaging of in vivo early fistula healing in perianal Crohn’s disease: PERSIST study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505317-25-00
Acronym
NL53558.018.22
Enrollment
10
Registered
2023-07-28
Start date
2023-11-24
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

perianal Crohn's fistula

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

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026