A Non-invasive Diagnostic Model for Intestinal Fibrosis in Crohn's Disease Based on 18F-FAPI PET Imaging

NCT05824962 | Unknown

• 1 other identifier: 2022355
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease (CD) is a chronic transmural inflammatory bowel disease. Prolonged episodes of inflammation can lead to intestinal fibrosis, leading to intestinal stenosis and obstruction. Inflammatory stenosis can be alleviated through anti-inflammatory treatment, while fibrotic stenosis requires endoscopic dilation or surgical treatment. Early detection of the presence and severity of intestinal fibrosis in CD is the key to treatment strategies. Currently, there are certain limitations in the non-invasive evaluation methods for intestinal fibrosis, and it is urgent to develop a new imaging method to achieve non-invasive diagnosis of the degree of fibrosis. Fibroblast activation protein (FAP) is a marker of intestinal fibrosis in CD. Based on the principle that fibroblast activation protein inhibitor (FAPI) can specifically bind to FAP, FAPI radioactive tracers can achieve targeted tracing and quantification of FAP in vivo. Therefore, 18F-FAPI positron emission tomography (PET) imaging technology has a good application prospect in the noninvasive diagnosis and evaluation of CD intestinal fibrosis. Based on the successful testing of 18F-FAPI PET imaging in the early stage of the project team to evaluate the nature of CD intestinal stenosis, this project intends to take patients with CD intestinal stenosis as the research object, and use postoperative histopathological analysis as a reference index to evaluate the role of 18F-FAPI combined with 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging in the qualitative diagnosis of CD intestinal wall fibrosis, as well as the differential diagnosis ability of inflammatory and fibrous stenosis in CD patients, and establish a diagnostic model and evaluation system. Achieving a noninvasive, stable, and objective diagnosis and evaluation of the degree of intestinal fibrosis in CD patients at the molecular level will provide imaging evidence for treatment decision-making, progress, and prognosis of CD patients, and also play an important support role in the development of anti fibrosis drugs, selection of suitable patients, and efficacy evaluation.

Conditions

Crohn Disease

Keywords

Crohn Disease; FDG; FAPI; Fibrosis; PET/CT

Outcome Measures

Primary Outcomes (3)

• Histologic Scores for Inflammatory

  Paraffin section specimens were stained by using hematoxylin and eosin for the histologic inflammation score. Two pathologists graded the histologic slices from the most severe areas for inflammation by using a semiquantitative scoring system. The inflammation score was scored between 0 and 3 points as follows: 0: none (No inflammation or distortion), 1: mild (Lamina propria inflammation only), 2: moderate (Submucosal foci of inflammation and/or foci of transmural inflammation), 3: severe (Significant, dissecting, confluent transmural inflammation).

  Completed within one week after surgery

• Histologic Scores for Fibrotic

  Paraffin section specimens were stained by using Masson trichrome for the histologic fibrosis score. Two pathologists graded the histologic slices from the most severe areas for fibrosis by using a semiquantitative scoring system. The fibrosis score was scored between 0 and 3 points as follows: 0: none (No fibrosis), 1: mild (Minimal fibrosis in submucosa or subserosa), 2: moderate (Increased submucosal fibrosis, septa into muscularis propria and/or septa through muscularis propria, increase in subserosal collage), 3: severe (Significant transmural scar, marked subserosal collagen).

  Completed within one week after surgery

• Metabolic parameters

  Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.

  Completed within one week after PET examination

Secondary Outcomes (4)

• FAP expression and SUV

  through study completion, an average of 1 year

• GLUT-1 expression and SUV

  through study completion, an average of 1 year

• Inflammatory histological score and SUV

  through study completion, an average of 1 year

• Fibrotic histological score and SUV

  through study completion, an average of 1 year

Eligibility Criteria

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

Study Population

The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.

You may qualify if:

• Patients diagnosed with CD based on clinical, imaging, endoscopic, and histopathological criteria;
• Patient age ≥ 18 years old;
• Within 15 days before surgery, 18F-FAPI, 18F-FDG PET/CT intestinal imaging, and routine CTE imaging were performed;
• Surgical resection of intestinal segments and imaging evaluation of intestinal segment matching;
• The pathological analysis of surgical specimens includes H\&E, Masson, GLUT1 and FAP immunohistochemical staining;
• The patient voluntarily participates and signs an informed consent form.

You may not qualify if:

• Pregnant or lactating patients;
• The quality of imaging images is poor and cannot be used for diagnosis and evaluation;
• If the pathological section of the specimen does not cover the entire intestinal wall;
• The fasting blood glucose level is higher than 11.1mmol/L;
• Patients with contraindications for CTE examination.

Sponsors & Collaborators

• Xiao Chen: lead

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (1)

• Scharitzer M, Macher-Beer A, Mang T, Unger LW, Haug A, Reinisch W, Weber M, Nakuz T, Nics L, Hacker M, Bergmann M, Rasul S. Evaluation of Intestinal Fibrosis with 68Ga-FAPI PET/MR Enterography in Crohn Disease. Radiology. 2023 May;307(3):e222389. doi: 10.1148/radiol.222389. Epub 2023 Feb 28.

  PMID: 36853176 BACKGROUND

Related Links

• Evaluation of Intestinal Fibrosis with 68Ga-FAPI PET/MR Enterography in Crohn Disease

Biospecimen

Retention: SAMPLES WITHOUT DNA

surgical bowel resection specimens

MeSH Terms

Conditions

Crohn Disease; Fibrosis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiao Chen, Ph.D

  Daping Hospital, Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Chen, Ph.D

CONTACT

15922970174; xiaochen229@foxmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 24, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)