The objective for this study is to investigate different types of techniques and strategies, in order to optimize scan-parameters, image quality and patient acceptance in Magnetic Resonance Colonography.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study is a pilot study with volunteers assigned to seven strategies and is
aimed to give a direction for a further study proposal. The main outcome
parameter is image-quality (lumen homogeneity) using different types of
dark-lumen colonography strategies.
Secondary outcome
Secondary outcome parameter is the acceptance of the preparation and MRC
examination using different types of contrast-tagging and rectal enemas.
Background summary
In order to assess the accuracy of Magnetic Resonance Colonography (MRC), a
number of comparative studies of MRC versus Conventional Colonoscopy (CC) have
been performed. Most of these studies describe a high variety of used
techniques, e.g. bright lumen, dark lumen, fecal tagging (FT), non-tagging,
bowel cleansing and different types of rectal enemas, resulting in a wide range
of observed sensitivity. At present the optimal scan parameters and bowel
preparation, aimed at high image quality and minimized patient burden, are not
known. To give direction towards a comparative study, first a pilot study is
performed comparing some *main stream* strategies as well as new approaches.
Study objective
The objective for this study is to investigate different types of techniques
and strategies, in order to optimize scan-parameters, image quality and patient
acceptance in Magnetic Resonance Colonography.
Study design
Prospective pilot study. A cohort of 21 healthy human volunteers will be
assigned to 7 types of different strategies (S) with the use of dark-lumen
colonography. Group 1 will receive gadolinium as contrast agent for fecal
tagging (S1), a standard preparation for bowel cleansing (S2) , oral barium
(S3) and oral Telebrix (S7) as contrast agent for fecal tagging and air/CO2
rectally. Group 2 will receive a low-fiber diet (S4) and no rectal enema.
Colonic distension is achieved by oral administration of an artificial sugar
solution (Mannitol). Group 3 receives oral barium (S5) or a standard
preparation for bowel cleansing (S6) and tap water rectally.
Study burden and risks
Risks for the subjects undergoing the MRC examination are minimal. MRC is a
diagnostic procedure so there are no direct therapeutic effects. There is a
minimal risk of a symptomatic bowel perforation. There is no benefit for the
healthy volunteers, except for a remuneration (150 euro) and reimbursement of
travel expenses. The outcome of this study will guide us towards a further
study on minimal bowel preparation for MRC, aimed at combining low burden bowel
preparation with high accuracy MRC for screening and surveillance programs.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Healthy volunteers (human) in the age of 18 - 75 years, who are willing to undergo MRC and bowel preparation and who want to give informed consent.
Exclusion criteria
- contraindications to undergo MRI (pacemakers, claustrophobia and pregnancy)
- contraindications for intravenous injection of Buscopan (including glaucoma or severe cardiac arrhythmia)
- contraindications for the usage of (iodine-based) Telebrix (including iodine contrast allergy, hyperthyroidism)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24407.018.08 |