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Recruiting NCT06604260

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

Phase II Interventional IBD (Inflammatory Bowel Disease) Crohn Disease (CD) Ulcerative Colitis (UC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-FAPi-46.
Who it may be relevant to
Registry conditions: IBD (Inflammatory Bowel Disease), Crohn Disease (CD), Ulcerative Colitis (UC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test 68Ga-FAPi-46
    68Ga FAPi PET-CT scan

Primary outcome measures

  • 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 in ulcerative colitis patients [Time frame: At baseline up to week 12 of study enrolment]
Secondary outcome measures (3)
  • Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi [Time frame: At baseline up to week 12 of study enrolment]
  • Protocol optimisation [Time frame: At baseline up to week 12 of study enrolment]
  • Minimal tracer injection dose [Time frame: At baseline up to week 12 of study enrolment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT06604260 · NL82160.029.22 · 2022-002751-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗