Translation of MR technique from research to clinical setting.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results of the additional MR technique are compared with those of
conventional MR techniques. The additional MR protocol is evaluated for their
added value, points for optimization are identified and these are included in
the continuous process of development. Scientifically relevant results from
this clinical pilot study will be published.
Endpoints: quantity of iron on T2 * MRI, LIF score, fat fraction
Secondary outcome
Not applicable
Background summary
MR is a technique that is constantly evolving. One of the potentially new
applications of a new MR protocol concerns the measurement of iron levels in
the body, and specifically in gastrointestinal tumors. This application appears
to be very interesting since scientific research has shown that iron seems to
play an important role in almost all aspects of both cancer development and
cancer growth. This technique can only be fully optimized in sensitivity and
specificity when patient data is available. To promote this MR technique, it is
important to conduct a pilot study, specifically in patients presenting with a
gastrointestinal tumor who receive an MRI as part of the standard diagnostic
procedure. In the future, for example, the MR technique can be used to measure
the effect of iron chelation, which is currently investigated as a new
anticancer therapy.
Study objective
Translation of MR technique from research to clinical setting.
Study design
Observational. Patient participation implies extension of the clinical MR scan
with the additional MR technique. The research concerns the non-invasive
assessment of the iron content in gastrointestinal tumors by means of T2 * MRI.
Study burden and risks
MR acquisitions will be added to the conventional clinical MR scans, with a
maximum extension of 15 minutes. The new MR technique does not include
administration of extra contrast fluid / medication. Additionally, patients
will be asked to stay sober 4 hours in advance, and blood will be taken for
interpretation of the MR data.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
All patients with gastrointestinal cancer (including rectum cancer, colon cancer with liver metastasis, pancreatic cancer) and with a clinical indication for MR examination
Exclusion criteria
All contra-indications for MR examinations (claustrophobia, cardiac pacemaker, implants not approved for MR at the employed field-strength, metal objects, etc)
Incapable to undergo prolonged MR examinatio n additonal to clinical MR examination (due to frailty of old age, general condition, etc).
No informed consent for notification of study participation to the medical specialist.
No informed consent for the work-up of incidental findings.
Design
Recruitment
metc-ldd@lumc.nl
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 | NL67569.058.18 |