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

Launched by DALIA LARTEY · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 68Ga-FAPi PET/CT to see if it can help detect fibrosis in the intestines of patients with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. Fibrosis is the thickening and scarring of tissue that can occur in these diseases, and finding ways to identify it early can help improve treatment options.

To participate in this trial, you need to be an adult aged 18 or older with a confirmed diagnosis of either Crohn's disease or ulcerative colitis. You should have active symptoms, such as abdominal pain or diarrhea, and your doctor should be able to confirm that you have active disease through tests like endoscopy or imaging. If you are pregnant, have had certain surgeries in the last five years, or have other specific health issues, you may not be eligible. If you join the study, you can expect to undergo imaging tests to help researchers learn more about how this new method works in detecting intestinal fibrosis in patients like you.

Gender

ALL

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