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

Phase 2RecruitingNCT06604260

Dalia Lartey20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

IBD (Inflammatory Bowel Disease)Crohn Disease (CD)Ulcerative Colitis (UC)

Interventions

68Ga-FAPi-46DIAGNOSTIC_TEST

68Ga FAPi PET-CT scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

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).

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

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

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).

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

Secondary Outcomes

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

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).

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

Protocol optimisation

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

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

Minimal tracer injection dose

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

Central Contacts

Dalia A Lartey, MD

CONTACT

+31205668160 d.a.lartey@amsterdamumc.nl

Data from ClinicalTrials.gov

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