The aim of this study is to investigate whether DWIBS is appropriate for colorectal cancer screening.
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
Sensitivity, specificity, positive predictive value and negative predictive
value of DWIBS (with 95% confidence intervals) for the detection of relevant
colorectal lesions (carcinomas and polyps >= 6mm).
Secondary outcome
N.A.
Background summary
In the Western world colorectal cancer is the second most common cancer in
women and the third most common in men. The lifetime incidence of colorectal
cancer in people at average risk is 5% and the age standardised incidence rate
is 44.3 per 100,000 population. Early detection of colorectal cancer
significantly improves survival. Current screening techniques (among which
faecal occult blood testing, sigmoidoscopy, colonoscopy, double contrast barium
enema, and computed tomographic virtual colonoscopie) are a burden to the
patient, have a risk of complications, and/or are not sufficiently accurate.
The recently developed diffusion-weighted whole-body imaging with background
body signal suppression (DWIBS)-sequence is an MRI-technique with high
potential for colorectal cancer screening. Compared to current screening
techniques, advantages of DWIBS are its non-invasiveness (no contrast agents
have to be applied), relatively little discomfort to the patient (no bowel
preparation, no invasive, internal investigation), its safety (no risk of
complications), the absence of radiation burden, an acceptable scanning time
(approximately 20-25 minutes), and a relatively fast interpretation of the
obtained images.
Study objective
The aim of this study is to investigate whether DWIBS is appropriate for
colorectal cancer screening.
Study design
This will be a unicenter, prospective, diagnostic cohort study (timeschedule:
24 months). 390 eligible patients will undergo a DWIBS-scan prior to the
already scheduled colonoscopy.
Study burden and risks
The patient has to lie in the MRI-scanner for approximately 20-25 minuten. The
MRI-scan is completely non-invasive and without any adverse side-effects.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
-Patients who are planned to undergo a colonoscopy in the UMC Utrecht because of suspected colorectal cancer, and having at least one of the following symptoms/signs: rectal bleeding, change in bowel habit, inexplicable weight loss, abdominal pain, and/or anemia
-Age: 50 years and older
-Written informed consent
Exclusion criteria
-Patients with a general contraindication for MRI (including cardiovascular pacemakers, claustrophobia)
-Patients who have had a previous malignancy
-Patients who are pregnant or nursing
-Patients in whom therapy has already started
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 | NL23040.041.08 |