Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02364973 |
| Other study ID # |
T31/2014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2014 |
| Est. completion date |
August 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Turku University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main purpose of the present study is to examine the diagnostic performance of combined
PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative
colitis and Crohn's disease.
Description:
COMBINED PET-MRI IN THE DIAGNOSTICS OF CHRONIC INFLAMMATORY BOWEL DISEASES (IBD)- A
FEASIBILITY STUDY (RESEARCH CODE T31/2014)
1. Background
Ulcerative colitis and Crohn's disease are chronic inflammatory bowel diseases (IBD)
with relapsing and remitting course. The incidence of IBD is highest in teenagers and
young adults, but IBD may also affect children and old people. The diagnosis of IBD is
based on clinical symptoms, endoscopy and histology of the bowel wall.
Aims of the study
The main purpose of the present study is to examine the diagnostic performance of
combined PET-MRI in detecting colonic and small bowel wall inflammatory processes caused
by ulcerative colitis and Crohn's disease.
The hypothesis of the study is a) IBD-related inflammatory changes are detected by
PET-MRI (18 F-FDG) and correlate with the endoscopic and histologic activity of colitis
and ileitis.
Study design
A total of 45 IBD patients (ulcerative colitis or Crohn's disease) aged over 15 years
will be recruited from the patients visiting outpatient gastroenterology clinic of Turku
University Hospital. Every patient undergoes colonoscopy with biopsy specimens,
endoscopic and histologic data are recorded via structured forms. Laboratory specimens
with samples for biobank are obtained. Then the patients are examined by abdominal MRI
and PET.
Inclusion criteria:
- informed consent obtained
- age over 18 years
- diagnosis of ulcerative colitis or Crohn's colitis based on endoscopy and histology
- the activity of colitis confirmed by histology and/or elevated fecal calprotectin
concentration
- fertile women have contraception
- no previous abdominal surgery
- no X-ray investtigations during preceding year
2. Investigators
Principal investigator Markku Voutilainen, MD, Department of Gastroenterology
Other investigators Hannu Aronen, Sami Kajander, Johanna Virtanen, Virva Saunavaara,
Department of Radiology and PET center.
Mervi Tenhami, Saila Kauhanen, Department of surgery
Pirjo Nuutila, Department of Endocrinology and PET center
Jukka Kemppainen, physicist, PET center
Olli Carpen, Department of pathology
Ville Aalto, statistician, University of Turku,
3. PET tracer is 18 F-FDG, dose 280 megabequerel (MBq, bowel imaging)
4. Data of scans and details of scanning time (including positioning and transmission) by
tracer, blood sampling (activity, metabolites)
- Before scanning: oral contrast intake (Mannitol dilution) 65 min
- Magnetic resonance imaging (MRI) positioning (prone position) 5min
- Abdominal MRI Scanning: 50min
- Region: from diaphragma to symphysis
- During the scan: i.v. Buscopan and +Gadolinium
- Sequences (fast gradient echo, predominantly breath-hold imaging):
1. T2 (field echo type) cor and ax
2. T2
3. T1 fs cor and ax +Gd
4. T1 fs repeated (start at 40 seconds after injection)
5. Diffusion
6. T2 or T1 cor +aks
- PET, FDG tracer: 15 min
- Total scanning time including positioning, MRI and PET: 70 min
Scanning code JN5JS (= Large scale PET-MRI of the body)
5. Number of study subjects 45
6. Scanner PET/MRI
7. The radiation dose will be calculated by physicist after the tracer, it's amount and
detector are determined. The permission from ethical committee was obtained in August
2014..
8. No quality issues (QA), routine radiological quality control
9. The study has been accepted by the Ethical committee of Turku University Hospital
10. Present study is academic study and all data relating to the study belongs to the
investigators.
11. The test patients are to undergo the study in September 2014. The study is to be started
October 2014.
12. For the financing of the study, VTR-/EVO-funding (Funding from the Finnish government)
will be applied. At present, 6000€ have been obtained from research funding of
Department of internal medicine.
