Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555042
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of VAP-1 Expression and Tissue Blood Flow by Combined 68GaDOTA-Siglec-9 and 15OH2O PET-MRI in Patients With Small Bowels Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAP-PET
Brief Summary:
This is an observational single center imaging study The CD patients with active disease will be assessed by 68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE Patients with high clinical suspicion of small intestines 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 remissioninadequacy of the treatment
Assessments for CD clinical disease activity will be performed at screening and 68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE assessments will be performed within a month for each patient
After PETMRE all patients can be treated according to patients needs with immunosuppressive drugs Follow-up visits are organized at after PETMRE imaging at gastroenterology outpatient clinic
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 remissioninadequacy of the treatment
Assessments for CD clinical disease activity will be performed at screening and 68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE assessments will be performed within a month for each patient
After PETMRE all patients can be treated according to patients needs with immunosuppressive drugs Follow-up visits are organized at after PETMRE imaging at gastroenterology outpatient clinic
Detailed Description:
Patients with a strong suspicion of small bowels 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 68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE the MRE being part of their clinical diagnostics If the MRE shows no signsor 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 patients blood sample calprotectin and faecal microbiota will be analysed from stool The tissue samples for immunohistological 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 serumplasma 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 PETMRE 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
68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE 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 PETMRE scanner arms next to the body Ideally urinary bladder should be empty before PETMRE 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
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 patients blood sample calprotectin and faecal microbiota will be analysed from stool The tissue samples for immunohistological 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 serumplasma 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 PETMRE 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
68GaGa-DOTA-Siglec-9 and 15OH2O PETMRE 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 PETMRE scanner arms next to the body Ideally urinary bladder should be empty before PETMRE 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None