The aim of the present study is to measure the test-retest reproducibility of DW-MRI in healthy volunteers, in patients with colorectal liver metastases and in patients with malignant lung lesions in a multicenter setting.
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reproducibility of apparent diffusion coefficient (ADC) measured with DW-MRI.
Secondary outcome
n/a
Background summary
To detect changes in multiple diffusion-weighted magnetic resonance imaging
(DW-MRI) scans in one patient, test-retest variability needs to be determined,
to know when an observed difference is due to a true biological effect.
Study objective
The aim of the present study is to measure the test-retest reproducibility of
DW-MRI in healthy volunteers, in patients with colorectal liver metastases and
in patients with malignant lung lesions in a multicenter setting.
Study design
Prospective multicenter international observational study including 20
volunteers, 25 patients with colorectal liver metastases, and 25 patients with
malignant lung lesions. All subjects will be scanned on two separate occasions
(within one week), without intervening therapy. Personal characteristics will
be registered (age, sex, bodyweight, height).
Study burden and risks
n/a
de Boelelaan 1117 (4F11)
Amsterdam 1081 HV
NL
de Boelelaan 1117 (4F11)
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Volunteer study
* Age 30-50 or 60-80 years
* Able to remain supine for 30 minutes in the scanner
* Written informed consent
Patient study
* Age 18 years or older
* Colorectal liver metastases or lung metastases, or primary lung cancer (histological confirmation only in uncertain metastatic deposits)
* Minimum of one lesion > 2cm in diameter in liver or lung respectively
* Able to remain supine for 30 minutes in the scanner
* Written informed consent
Exclusion criteria
* Contraindications for MRI
* Antitumor treatment targeted on the evaluable liver metastasis
* Antitumor treatment targeted less than 1 week prior to scan in malignant lung lesions
* Claustrophobia
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 | NL41864.029.12 |