Crohn DiseaseNCT05824962
A Non-invasive Diagnostic Model for Intestinal Fibrosis in Crohn's Disease Based on 18F-FAPI PET Imaging
An observational study of Crohn Disease, run by Xiao Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400010
Xiao Chen, Ph.D, 15922970174, xiaochen229@foxmail.com
About this study
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.
Read the detailed description
This study is a prospective, multicenter study and has been approved by the ethics committee. The subjects of this study were from January 1, 2023 to December 31, 2025.The detailed description is as follows：
- Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
- Clinical data collection: Record the course of disease, PET/computed tomography (CT) examination, computed-tomography enterography(CTE) examination and surgical interval, lesion location, CD activity index, laboratory examination (blood routine, C-reactive protein, erythrocyte sedimentation rate), and other information of all patients.
- CTE image analysis： Record and evaluate the following indicators: location and length of abnormal small intestine segments, intestinal stenosis, intestinal wall thickness, pre stenosis dilation, ratio of proximal small intestine dilation diameter to the minimum lumen diameter within the stenosis. In addition, record submucosal edema, submucosal fat infiltration, adjacent mesenteric inflammation, abdominal abscess, fistula, etc.
- PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptake value (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
- Pathological analysis: After surgery, the most significant lesion of the intestinal wall was removed for pathological staining. Select normal specimens near the surgical resection edge as the control group. The hematoxylin and eosin (H\&E) staining was used to evaluate intestinal wall inflammation; Masson staining was used to evaluate intestinal fibrosis; Immunohistochemical analysis was used to investigate the expression of FAP and glucose transporter protein 1 (GLUT-1).
- Statistical analysis: Spearman correlation analysis was used to evaluate the correlation between intestinal wall FAP expression level and fibrosis score, as well as the correlation between imaging indicators and fibrosis score, inflammation score, and FAP expression level. Single factor analysis of variance was used to compare the imaging indicators of intestinal wall in four groups with different degrees of fibrosis, and the least significant difference(LSD) method was used for pairwise comparison. Using multivariate logistic regression analysis, and using the forward method and likelihood ratio test to screen variables, independent factors were determined for predicting intestinal fibrosis in lesions using the column chart. Based on the results of multivariate logistic regression analysis, a column chart prediction model was established using the "RMS" program package in R3.6.1 software. The Harrell consistency index of the model construction group was calculated, and a bootstrap calibration curve was drawn to internally verify the predictive performance of the column chart. The Harrell consistency index of the model validation group was calculated to externally verify its predictive performance. Evaluate the diagnostic performance of each variable using subject operated characteristic curve analysis, and calculate the area, sensitivity, specificity, and threshold under each variable curve. Compare the diagnostic efficacy of PET/CT and CTE using Medcalc software.
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, FDG, FAPI, Fibrosis, PET/CT
- Medical subject headings
- Crohn Disease, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Completed within one week after surgery
Metabolic parameters
Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.
Measured: Completed within one week after PET examination
Secondary outcomes (4)
FAP expression and SUV
Correlation between FAP expression and SUV in PET
Measured: through study completion, an average of 1 year
GLUT-1 expression and SUV
Correlation between GLUT-1 expression and SUV in PET
Measured: through study completion, an average of 1 year
Inflammatory histological score and SUV
Correlation between inflammatory histological score and SUV in PET
Measured: through study completion, an average of 1 year
Fibrotic histological score and SUV
Correlation between fibrotic histological score and SUV in PET
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Xiao Chen, Ph.D, Principal investigator, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824962
- Sponsor's protocol ID
- 2022355
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36853176
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-invasive Diagnostic Model for Intestinal Fibrosis in Crohn's Disease Based on 18F-FAPI PET Imaging
- ClinicalTrials.gov ID
- NCT05824962
- Acronym / sponsor ID
- 2022355
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, FDG, FAPI, Fibrosis, PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xiao ChenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, multicenter study and has been approved by the ethics committee. The subjects of this study were from January 1, 2023 to December 31, 2025.The detailed description is as follows：
- Patients: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
- Clinical data collection: Record the course of disease, PET/computed tomography (CT) examination, computed-tomography enterography(CTE) examination and surgical interval, lesion location, CD activity index, laboratory examination (blood routine, C-reactive protein, erythrocyte sedimentation rate), and other information of all patients.
- CTE image analysis： Record and evaluate the following indicators: location and length of abnormal small intestine segments, intestinal stenosis, intestinal wall thickness, pre stenosis dilation, ratio of proximal small intestine dilation diameter to the minimum lumen diameter within the stenosis. In addition, record submucosal edema, submucosal fat infiltration, adjacent mesenteric inflammation, abdominal abscess, fistula, etc.
- PET image analysis: Record and evaluate the following indicators: the maximum, mean and peak standardized uptake value (SUVmax, SUVmean and SUVpeak), Metabolic lesion volume (MLV), total lesion glycolysis (TLG).
- Pathological analysis: After surgery, the most significant lesion of the intestinal wall was removed for pathological staining. Select normal specimens near the surgical resection edge as the control group. The hematoxylin and eosin (H\&E) staining was used to evaluate intestinal wall inflammation; Masson staining was used to evaluate intestinal fibrosis; Immunohistochemical analysis was used to investigate the expression of FAP and glucose transporter protein 1 (GLUT-1).
- Statistical analysis: Spearman correlation analysis was used to evaluate the correlation between intestinal wall FAP expression level and fibrosis score, as well as the correlation between imaging indicators and fibrosis score, inflammation score, and FAP expression level. Single factor analysis of variance was used to compare the imaging indicators of intestinal wall in four groups with different degrees of fibrosis, and the least significant difference(LSD) method was used for pairwise comparison. Using multivariate logistic regression analysis, and using the forward method and likelihood ratio test to screen variables, independent factors were determined for predicting intestinal fibrosis in lesions using the column chart. Based on the results of multivariate logistic regression analysis, a column chart prediction model was established using the "RMS" program package in R3.6.1 software. The Harrell consistency index of the model construction group was calculated, and a bootstrap calibration curve was drawn to internally verify the predictive performance of the column chart. The Harrell consistency index of the model validation group was calculated to externally verify its predictive performance. Evaluate the diagnostic performance of each variable using subject operated characteristic curve analysis, and calculate the area, sensitivity, specificity, and threshold under each variable curve. Compare the diagnostic efficacy of PET/CT and CTE using Medcalc software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects we selected are adults who are not restricted by gender. For details, please refer to the "Eligibility Criteria" column.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histologic Scores for Inflammatory
Time frame: Completed within one week after surgery
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).
Histologic Scores for Fibrotic
Time frame: Completed within one week after surgery
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).
Metabolic parameters
Time frame: Completed within one week after PET examination
Total Lesion Glycolysis (TLG) of bowel lesions are measured on PET.
4 secondary outcomes
FAP expression and SUV
Time frame: through study completion, an average of 1 year
GLUT-1 expression and SUV
Time frame: through study completion, an average of 1 year
Inflammatory histological score and SUV
Time frame: through study completion, an average of 1 year
Fibrotic histological score and SUV
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 36853176Scharitzer 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.
- Evaluation of Intestinal Fibrosis with 68Ga-FAPI PET/MR Enterography in Crohn DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Chen, Ph.D principal investigator
Daping Hospital, Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Xiao Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chen, Ph.D (15922970174, xiaochen229@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Scores for Inflammatory (time frame: Completed within one week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.