Currently, only few publications exist which describe MRI for esophageal cancer. Therefore, the objective of the study is to develop a MRI protocol for imaging of this organ. The research will particularly be focussed on functional MRI. Those scans…
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
Quality of the MRI images.
Secondary outcome
-
Background summary
Esophageal cancer remains one of the most lethal cancers, despite the
introduction of multimodality treatment (e.g. radiotherapy). The average 5-year
survival is just 15-20%. Furthermore, the incidence of esophageal cancer has
doubles over past 2 decades. Survival rates are low due to poor loco-regional
control. It is expected that radiotherapy treatment can be improved by better
visualization of the tumour. This way, irradiation can be better targeted to
the tumour. It seems also relevant to identify patients with good response to
radiotherapy. Some 30-50% of the patients are characterized as complete
responders after surgery. For those patients, surgery may not be necessary. To
improve tumour visualization and treatment response, MRI seems a promising
technique. MRI is known for its good soft-tissue contrast. It was also shown
that functional MRI techniques can useful to predict complete response of
tumours after radiotherapy.
Study objective
Currently, only few publications exist which describe MRI for esophageal
cancer. Therefore, the objective of the study is to develop a MRI protocol for
imaging of this organ. The research will particularly be focussed on functional
MRI. Those scans are suited for treatment response monitoring.
Study design
Observational study.
Study burden and risks
The patient will undergo an MR exam. No ionizing radiation is used to make an
MRI scan; MRI scanning is a safe procedure. The MR exam lasts 45 minutes, the
total time of the visit is expected to be an hour. To reduce the burden for the
patient, we strive to plan the MR exam and other (conventional) exams or
treatments on the same day. Each patient will be asked to undergo 2 or 3 MRI
scans prior and/or during the course of radiotherapy.
Before the MR exam can take place, the glomerular filtration rate (GFR) needs
to be known. If no recent value (< 3 months) is known, a venapunction is
required. The majority of the patients, however, will have a recent GFR value
available as it is required for conventional treatment planning
(contrast-enhanced CT).
During the MR exam, an intravenous contrast agent is administered to the
patient. This can lead to side effects: headache, nausea, injection side
reaction, disturbed sense of taste and feeling hot. The use of the contrast
agent has a very low risk of a allergic reaction to the contrast medium.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-Patients with pathologically proven esophageal cancer referred to the department of Radiotherapy for radiotherapy.
>18 years
-Written informed consent
Exclusion criteria
- Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMCU protocol *Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012*. In patients with risk factors a GFR of 60 mL/min/1.73m2 will be required.
- Known Gadovist allergy.
- Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht
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 | NL42338.041.12 |
| Other | TC3852 |