Crohn DiseaseVAP-PETNCT06555042
Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease
An observational study of Crohn Disease and Inflammatory Bowel Diseases, run by Turku University Hospital at 1 site in Finland.
Trial summary
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Crohn Disease of Small Intestine
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2024to 6 Jun 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a strong suspicion of small bowel's CD after the colonoscopy and laboratory studies will be recruited to study protocol in the outpatient gastroenterology clinic of Turku University Hospital.
Who may be able to join
- Adults between age 18-70
- Strong clinical suspicion of small bowel Crohn's disease
- Able and willing to give written informed consent and to comply with the study protocol
Who cannot join
- Pregnant or breast-feeding women
- Previous capsule retention
- X-ray investigations during preceding year
- Patients with metallic implants such as an electronic pacemaker or an implanted infusion pump
- Known stenosis of the GI-tract
- Evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the Investigator, would preclude patient participation
- Is unable or unwilling to comply with the study protocol for any reason
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku PET Centre
Turku, Southwest Finland, 20540
Pirjo Nuutila, M.D., Ph.D., +35823130000, pirjo.nuutila@utu.fi
Kari Kalliokoski, Ph.D., +35823130000, kari.kalliokoski@utu.fi
About this study
Official title: Investigation of VAP-1 Expression and Tissue Blood Flow by Combined [68Ga]DOTA-Siglec-9 and [15O]H2O PET-MRI in Patients With Small Bowel's Crohn's Disease
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study.
20 patients with high suspicion of active small bowels CD will be enrolled to being evaluated for potential participation in this study. In patients with diagnosed small bowels CD, PET-MRE will be repeated 3 months after the initial imaging (and based on clinical diagnostic started medication) to verify disease remission/inadequacy of the treatment.
Read more
Assessments for CD clinical disease activity will be performed at screening and [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE assessments will be performed within a month for each patient.
After PET/MRE all patients can be treated according to patients' needs with immunosuppressive drugs. Follow-up visits are organized at after PET/MRE imaging at gastroenterology outpatient clinic.
Read the detailed description
Patients with a strong suspicion of small bowel's CD after the colonoscopy and laboratory studies will be recruited to study protocol in the outpatient gastroenterology clinic of Turku University Hospital. After the signed informed consent patients will undergo combined [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE, the MRE being part of their clinical diagnostics. If the MRE shows no signs/or mild inflammation of small intestine CD patients will be directed to small bowel capsule endoscopy (SBCE), which is routine in this clinical suspicion.
The patients will also have routine blood samples taken. A complete blood count (CBC), C-reactive protein (CRP), creatinine, alanine aminotransferase (ALAT), alkaline phosphatase (AFOS) and albumin will be analysed from each patient's blood sample, calprotectin and faecal microbiota will be analysed from stool. The tissue samples for (immuno)histological evaluation, proteome-wide mass spectrometry allowing sensitive site-specific detection of ADP-ribosylation and structural protein analysis will also be obtained in primary ileocolonoscopy (biopsies from the bowel wall).
Before the PET study starts, the patients will undergo screening procedures with physical examination, chemistry panel (electrolytes, creatinine, liver function), and acute phase reactants (ESR, CRP) and urine tests. In addition, serum/plasma biomarker sample, serum sample for soluble VAP-1 analysis, whole blood RNA sample, and whole blood DNA sample for gene variant analyses will be collected.
In the combined PET/MRE scanning the study subjects lay in the prone position on the PET scanner bed, and the area of interest (AOI) is positioned in the gantry and in the field of view.
[68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE imaging will be performed in the fasting state (at least 6 hours). The patients will be instructed to avoid caffeinated drinks during the last 24-hours before the study. A catheter will be inserted in an antecubital vein for injection of PET radiopharmaceutical. Another catheter will be inserted in the opposite radial or antecubital vein for blood sampling and the subjects will be placed in supine position in the PET/MRE scanner, arms next to the body. Ideally, urinary bladder should be empty before PET/MRE scan. The uptake of tracer will be measured using PET and MRE will be performed for anatomical reference.
After PET scans, the patients with CD will be treated and followed by gastroenterologist according to the current guidelines.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Crohn Disease of Small Intestine, Crohn Colitis, Crohn's Ileocolitis, Crohn Disease in Remission
- Keywords
- Inflammatory Bowel Disease, Positron emission tomography, Crohn's disease, Vascular adhesion protein-1, Intestinal Perfusion
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP-1 expression in the small bowel of patients with Crohn's disease
VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by [68Ga]Ga-DOTA-Siglec-9 PET/MRE.
Measured: 18 months
Secondary outcomes (2)
VAP-1 immunohistochemistry
VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by immunohistochemical staining of tissue biopsies.
Measured: 18 months
Tissue perfusion
Intestinal blood flow is increased in inflamed small bowel and decreased in the late fibrosing stages of Crohn's disease.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study startSep 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion6 Jun 2026 (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 Turku University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Jukka Koffert, Turku University Hospital
- Investigators
- Jukka Koffert, M.D., Ph.D, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555042
- Sponsor's protocol ID
- VARHA/4573/13.02.02/2024
- Acronym
- VAP-PET
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of VAP-1 Expression and Tissue Blood Flow by Combined [68Ga]DOTA-Siglec-9 and [15O]H2O PET-MRI in Patients With Small Bowel's Crohn's Disease
- ClinicalTrials.gov ID
- NCT06555042
- Acronym / sponsor ID
- VAP-PET / VARHA/4573/13.02.02/2024
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Crohn Disease of Small Intestine, Crohn Colitis, Crohn's Ileocolitis, Crohn Disease in Remission
- Keywords
- Inflammatory Bowel Disease, Positron emission tomography, Crohn's disease, Vascular adhesion protein-1, Intestinal Perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- Sep 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 15 Aug 2024 (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.
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study.
20 patients with high suspicion of active small bowels CD will be enrolled to being evaluated for potential participation in this study. In patients with diagnosed small bowels CD, PET-MRE will be repeated 3 months after the initial imaging (and based on clinical diagnostic started medication) to verify disease remission/inadequacy of the treatment.
Assessments for CD clinical disease activity will be performed at screening and [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE assessments will be performed within a month for each patient.
After PET/MRE all patients can be treated according to patients' needs with immunosuppressive drugs. Follow-up visits are organized at after PET/MRE imaging at gastroenterology outpatient clinic.
Detailed description
Patients with a strong suspicion of small bowel's CD after the colonoscopy and laboratory studies will be recruited to study protocol in the outpatient gastroenterology clinic of Turku University Hospital. After the signed informed consent patients will undergo combined [68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE, the MRE being part of their clinical diagnostics. If the MRE shows no signs/or mild inflammation of small intestine CD patients will be directed to small bowel capsule endoscopy (SBCE), which is routine in this clinical suspicion.
The patients will also have routine blood samples taken. A complete blood count (CBC), C-reactive protein (CRP), creatinine, alanine aminotransferase (ALAT), alkaline phosphatase (AFOS) and albumin will be analysed from each patient's blood sample, calprotectin and faecal microbiota will be analysed from stool. The tissue samples for (immuno)histological evaluation, proteome-wide mass spectrometry allowing sensitive site-specific detection of ADP-ribosylation and structural protein analysis will also be obtained in primary ileocolonoscopy (biopsies from the bowel wall).
Before the PET study starts, the patients will undergo screening procedures with physical examination, chemistry panel (electrolytes, creatinine, liver function), and acute phase reactants (ESR, CRP) and urine tests. In addition, serum/plasma biomarker sample, serum sample for soluble VAP-1 analysis, whole blood RNA sample, and whole blood DNA sample for gene variant analyses will be collected.
In the combined PET/MRE scanning the study subjects lay in the prone position on the PET scanner bed, and the area of interest (AOI) is positioned in the gantry and in the field of view.
[68Ga]Ga-DOTA-Siglec-9 and [15O]H2O PET/MRE imaging will be performed in the fasting state (at least 6 hours). The patients will be instructed to avoid caffeinated drinks during the last 24-hours before the study. A catheter will be inserted in an antecubital vein for injection of PET radiopharmaceutical. Another catheter will be inserted in the opposite radial or antecubital vein for blood sampling and the subjects will be placed in supine position in the PET/MRE scanner, arms next to the body. Ideally, urinary bladder should be empty before PET/MRE scan. The uptake of tracer will be measured using PET and MRE will be performed for anatomical reference.
After PET scans, the patients with CD will be treated and followed by gastroenterologist according to the current guidelines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a strong suspicion of small bowel's CD after the colonoscopy and laboratory studies will be recruited to study protocol in the outpatient gastroenterology clinic of Turku University Hospital.
Key inclusion criteria (3 listed)
- Adults between age 18-70
- Strong clinical suspicion of small bowel Crohn's disease
- Able and willing to give written informed consent and to comply with the study protocol
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women
- Previous capsule retention
- X-ray investigations during preceding year
- Patients with metallic implants such as an electronic pacemaker or an implanted infusion pump
- Known stenosis of the GI-tract
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
VAP-1 expression in the small bowel of patients with Crohn's disease
Time frame: 18 months
VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by [68Ga]Ga-DOTA-Siglec-9 PET/MRE.
2 secondary outcomes
VAP-1 immunohistochemistry
Time frame: 18 months
Tissue perfusion
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Jukka Koffert, M.D., Ph.D principal investigator
Turku University Hospital
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 and Inflammatory Bowel Diseases, run by Turku University Hospital at 1 site in Finland.
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 3 inclusion and 7 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 15 Aug 2024. 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 Finland. 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 Jukka Koffert, Ph.D. (+35823130000, jukka.koffert@varha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP-1 expression in the small bowel of patients with Crohn's disease (time frame: 18 months). 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 15 Aug 2024.