Crohn DiseaseFILMNCT04467580
Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease
A study testing abdominal [18F]FDG PET/CT in people with Crohn Disease, run by Central Hospital, Nancy, France.
Trial summary
Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects 250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the terminal ileum, sometimes with obstructive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- abdominal [18F]FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 2 May 2023
- Phase
- Interventional
- 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
Who may be able to join
- Major subject having received complete information of the clinical research and having signed their informed consent
- Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy).
- Subject for which surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
- Subject with a social security scheme
Who cannot join
- Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG.
- Subject with an ostomy
- Diabetic subject treated by metformin.
- Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- Pregnant woman, parturient or nursing mother.
- Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
- Subject unable to express consent.
- Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L.3213-1.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Validation of an Inflammation Index (FILM-i) and a Fibrosis Index (FILM-f), Combining MRI and Positron Emission Tomography (PET) With Low-dose [18F]FDG (With the Tracer Fluorine-18 (18F) Fluorodeoxyglucose (FDG), Called [18F]FDG PET Activity, to Characterize Fibrosis and Inflammation of Intestinal Strictures During Crohn's Disease
Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects 250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the terminal ileum, sometimes with obstructive symptoms and requiring an optimization of medical treatment (biotherapies) and/or surgery The hypothesis of this study is [18F]FDG PET /CT, (Positron emission tomography with the tracer fluorine-18 (18F) fluorodeoxyglucose (FDG), called [18F]FDG PET coupled to a dedicated CT scanner) could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET /CT and MRI , in patients with complicated Crohn Disease intestinal stenosis
Read the detailed description
Intestinal inflammation could be quantified by the PET/CT due to the tropism of a PET tracer, [18F]FDG for activated inflammatory cells.
[18F]FDG PET/CTperformed on latest digital PET/CT cameras and recordings focused on the abdomen could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET/CT and MRI , in patients with complicated Crohn Disease intestinal stenosis.
Magnetic resonance imaging (MRI) indices are used to assess the upgradability and activity of CD and try to predict response to treatment, in particular Nancy's MRI score for digestive inflammation.
An inflammation index (FILM-i) and a fibrosis index (FILM-f), based on this MRI/PET analysis, will be developed and validated to develop personalized medicine in patients with stenosing CD. Indeed, these indices will guide the therapeutic choice, in particular for the biotherapies prescription or the need to operate these patients.
- Conditions
- Crohn Disease
- Being tested
- abdominal [18F]FDG PET/CT
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal [18F]FDG PET/CTDiagnostic test
Patients will have within a maximum period of 15 days before the surgery (resection of intestinal stenosis), records by MRI and by digital PET/CT with low injected activity of [18F]FDG, focused on the abdomen, the MRI will be performed maximum 30 days before the intervention (if available and performed according to the procedure for the study, it will not be repeated for the study).
| Study group | Role | What they receive |
|---|---|---|
| Patients with stenosing CD | Experimental | Patients with stenosing CD will be recruited in each investigation center, during a preoperative consultation for an already decided and planned intestinal resection (digestive surgery or hepato-gastro department) -enterology). Receives: Diagnostic Test: abdominal [18F]FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index FILM-i
Index FILM-i will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall: cellular infiltration and edema
These histological scores both include 4 grades:
- 0 = no damage (fibrosis or inflammation),
- 1 = slight damage,
- 2 = average achievement,
- 3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
Measured: Day 45
Index FILM-f
Index FILM-f will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall : collagen fibrosis
These histological scores both include 4 grades:
- 0 = no damage (fibrosis or inflammation),
- 1 = slight damage,
- 2 = average achievement,
- 3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
Measured: Day 45
Secondary outcomes (4)
Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
Quantify the contribution of [18F]FDG PET/CT, in addition to MRI, for the characterization of the fibrotic and inflammatory components of stenosis of the terminal ileum with the index NET. This index will be calculated to quantify the contribution of PET items to the model including only MRI items.
Measured: Day 45
To compare the performance of the inflammation index (FILM-i) with that of a baseline MRI score, the Nancy score, for the detection of significant colonic inflammation (moderate to severe in histopathology).
The performance of the FILM-i index and Nancy's score will be evaluated by the of correctly classified segments.
Measured: Day 45
Inter- and intra-observer reproducibility
To estimate the inter- and intra-observer reproducibility of the 4 grade classifications obtained by the FILM-i and FILM-f indices with the intra-class correlation coefficients.
Measured: Day 45
Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
Compare the results of index and modified GHAS score
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion2 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient with stenosing CD and for which the surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467580
- Sponsor's protocol ID
- 2020_003067-26
- Acronym
- FILM
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Inflammation Index (FILM-i) and a Fibrosis Index (FILM-f), Combining MRI and Positron Emission Tomography (PET) With Low-dose [18F]FDG (With the Tracer Fluorine-18 (18F) Fluorodeoxyglucose (FDG), Called [18F]FDG PET Activity, to Characterize Fibrosis and Inflammation of Intestinal Strictures During Crohn's Disease
- ClinicalTrials.gov ID
- NCT04467580
- Acronym / sponsor ID
- FILM / 2020_003067-26
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 2 May 2023 (estimated)
- First posted
- 13 Jul 2020 (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.
Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects 250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the terminal ileum, sometimes with obstructive symptoms and requiring an optimization of medical treatment (biotherapies) and/or surgery The hypothesis of this study is [18F]FDG PET /CT, (Positron emission tomography with the tracer fluorine-18 (18F) fluorodeoxyglucose (FDG), called [18F]FDG PET coupled to a dedicated CT scanner) could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET /CT and MRI , in patients with complicated Crohn Disease intestinal stenosis
Detailed description
Intestinal inflammation could be quantified by the PET/CT due to the tropism of a PET tracer, [18F]FDG for activated inflammatory cells.
[18F]FDG PET/CTperformed on latest digital PET/CT cameras and recordings focused on the abdomen could help quantify intestinal inflammation in patients with abnormal entero-MRI, and differentiate inflammation and fibrosis on a joint PET/CT and MRI , in patients with complicated Crohn Disease intestinal stenosis.
Magnetic resonance imaging (MRI) indices are used to assess the upgradability and activity of CD and try to predict response to treatment, in particular Nancy's MRI score for digestive inflammation.
An inflammation index (FILM-i) and a fibrosis index (FILM-f), based on this MRI/PET analysis, will be developed and validated to develop personalized medicine in patients with stenosing CD. Indeed, these indices will guide the therapeutic choice, in particular for the biotherapies prescription or the need to operate these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient with stenosing CD and for which the surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
| Arm | Type | Receives |
|---|---|---|
| Patients with stenosing CD | Experimental | Diagnostic Test: abdominal [18F]FDG PET/CTPatients with stenosing CD will be recruited in each investigation center, during a preoperative consultation for an already decided and planned intestinal resection (digestive surgery or hepato-gastro department) -enterology). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major subject having received complete information of the clinical research and having signed their informed consent
- Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy).
- Subject for which surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
- Subject with a social security scheme
Key exclusion criteria (8 listed)
- Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG.
- Subject with an ostomy
- Diabetic subject treated by metformin.
- Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
- Pregnant woman, parturient or nursing mother.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal [18F]FDG PET/CTPatients will have within a maximum period of 15 days before the surgery (resection of intestinal stenosis), records by MRI and by digital PET/CT with low injected activity of [18F]FDG, focused on the abdomen, the MRI will be performed maximum 30 days before the intervention (if available and performed according to the procedure for the study, it will not be repeated for the study). | Diagnostic test | Patients with stenosing CD |
Primary outcome
Index FILM-i
Time frame: Day 45
Index FILM-i will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall: cellular infiltration and edema These histological scores both include 4 grades: * 0 = no damage (fibrosis or inflammation), * 1 = slight damage, * 2 = average achievement, * 3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
Index FILM-f
Time frame: Day 45
Index FILM-f will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall : collagen fibrosis These histological scores both include 4 grades: * 0 = no damage (fibrosis or inflammation), * 1 = slight damage, * 2 = average achievement, * 3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
4 secondary outcomes
Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
Time frame: Day 45
To compare the performance of the inflammation index (FILM-i) with that of a baseline MRI score, the Nancy score, for the detection of significant colonic inflammation (moderate to severe in histopathology).
Time frame: Day 45
Inter- and intra-observer reproducibility
Time frame: Day 45
Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
Time frame: Day 45
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal [18F]FDG PET/CT in people with Crohn Disease, run by Central Hospital, Nancy, France.
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 4 inclusion and 8 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Marine CLAUDIN, MD (0383154276, m.claudin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index FILM-i (time frame: Day 45). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.