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NCT Number: NCT06604260

FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients

Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1081 BT, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1

  • Adults ≥18 years with confirmed diagnosis of Crohn's disease

AND one of the following:

  • Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
  • Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
  • Active disease confiremed by endoscopy ( endoscopic SES-CD score >3)
  • Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2
  • Adults ≥18 years with confirmed diagnosis of ulcerative colitis

AND one of the following:

  • Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
  • Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
  • Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)

Exclusion criteria

  • Pregnancy
  • Unable to provide informed consent
  • IBD-related surgeries < 5 years in medical history
  • Colorectal carcinoma

Treatment and study plan

68Ga-FAPi-46

Diagnostic Test

68Ga FAPi PET-CT scan

Other names: FAPi-scan

Primary outcomes

  1. Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients

    Time frame: At baseline up to week 12 of study enrolment

    Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).

  2. Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients

    Time frame: At baseline up to week 12 of study enrolment

    Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).

Secondary outcomes

  1. Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi

    Time frame: At baseline up to week 12 of study enrolment

    Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi in patients with a) Crohn's disease and b) ulcerative colitis compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi imaging studies in patients not suffering from IBD (when signed informed consent is available).

  2. Protocol optimisation

    Time frame: At baseline up to week 12 of study enrolment

    To define optimal (single and/or dual) time point(s) post injection for imaging FAP activity in Crohn's disease and ulcerative colitis.

  3. Minimal tracer injection dose

    Time frame: At baseline up to week 12 of study enrolment

    Determine the minimal tracer injection dose required to have comparable disease detection performance on PET as to the full tracer injection dose PET.

Other outcomes

  1. Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP

    Time frame: At baseline up to week 12 of study enrolment

    To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia A Lartey, MD

CONTACT

[email protected]

+31205668160

Sponsors and collaborators

Lead sponsor

Dalia Lartey

Other

Registry information

Acronym: PIMAFI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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