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

NCT06604260 | Recruiting Phase 2

• 2 other identifiers: NL82160.029.222022-002751-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

FAPI; fibroblast activation protein; FAP; FAPi-scan; 68Ga-FAPi PET-CT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  At baseline up to week 12 of study enrolment

• Protocol optimisation

  At baseline up to week 12 of study enrolment

• Minimal tracer injection dose

  At baseline up to week 12 of study enrolment

Other Outcomes (1)

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

  At baseline up to week 12 of study enrolment

Study Arms (1)

IBD patients

EXPERIMENTAL

Ulcerative colitis and Crohn's disease patients

Diagnostic Test: 68Ga-FAPi-46

Interventions

68Ga-FAPi-46 DIAGNOSTIC_TEST

68Ga FAPi PET-CT scan

Also known as: FAPi-scan

IBD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dalia Lartey: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081 BT, Netherlands

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Mark Lowenberg, MD PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia A Lartey, MD

CONTACT

+31205668160; d.a.lartey@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Drs

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: August 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)