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

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 Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD); Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Diagnostic test: 68Ga-FAPi-46

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dalia A Lartey, MD; Phone Number: +31205668160; Email: d.a.lartey@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 BT
      • Recruiting
      • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBD patients; Ulcerative colitis and Crohn's disease patients	Diagnostic test: 68Ga-FAPi-46; 68Ga FAPi PET-CT scan; Other Names: FAPi-scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	At baseline up to week 12 of study enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	At baseline up to week 12 of study enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correspondence 68Ga-FAPi bowel uptake conventional imaging modalities and cellular FAP	To determine to what extent 68Ga-FAPi bowel uptake in IBD patients corresponds to conventional imaging modalities and FAP protein and transcriptome expression levels.	At baseline up to week 12 of study enrolment

Collaborators and Investigators

• Sponsor: Dalia Lartey
• Investigators: Principal Investigator: Mark Lowenberg, MD PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: FAP; FAPI; fibroblast activation protein; FAPi-scan; 68Ga-FAPi PET-CT
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46
• Other Study ID Numbers: NL82160.029.22; 2022-002751-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No