Determine normal ADC values and the reproducibility of the ADC values in normal liver tissue and colorectal liver metastases in a multicentre trial. Determine the effect of lesion volume on reproducibility of the ADC values.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ADC values of normal liver, the liver metastases, the tumor volumes and the
reproducibility of the ADC values.
Secondary outcome
Not applicable
Background summary
Approximately 50% of primary colorectal cancers disseminates predominantly to
the liver. Irresectable metastatic colorectal cancer is treated with systemic
therapy. Since only 40%-60% of patients responds to this potentially toxic
treatment, early response monitoring is desirable. Several studies have shown
promising results for diffusion weighted imaging (DWI). Data on reproducibility
are essential to ascertain the magnitude of changes detectable in the apparent
diffusion coefficient (ADC). This is especially important for early response
evaluation, since changes shortly after start of treatment may be small.
Study objective
Determine normal ADC values and the reproducibility of the ADC values in normal
liver tissue and colorectal liver metastases in a multicentre trial. Determine
the effect of lesion volume on reproducibility of the ADC values.
Study design
The livers of 5 healthy volunteers and 5 patients with colorectal liver
metastases per participating centre will be scanned twice using DWI at 1.5T MRI
(Siemens Avanto).
Study burden and risks
The risk associated with study participation are very low. No contrast agent is
administered. No negative long term side effects of MRI are known to date. The
study is not suited for claustrophobic patients/volunteers. No benefit for
participants is to be expected. Burden: participants visit the clinic twice for
30-45 minutes to undergo both scans. For healthy volunteers and in lesser
extent the patients there is a risk for unexpected findings.
Avenue Mounierlaan 83/11
Brussel 1200
NL
Avenue Mounierlaan 83/11
Brussel 1200
NL
Listed location countries
Age
Inclusion criteria
Volunteers: 18 years and above.
Patients: at least one liver metastasis of histopathologically proven colorectal cancer
Exclusion criteria
Contra-indications for MRI: MRI-incompatible implants, pacemaker, claustrophobia;For patients: systemic treatment in the last 2 months prior to study participation
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 | NL41968.091.12 |