The objective of this study is to investigate the faesibility to fuse images of patholocial anatomy after uterusextirpation according to Wertheim-Okabayashi into tyhe pre-operative T2/DWI/DCE weighted MR images using non-rigid co-registration.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility of co-registration of the microscopic images of the surgical
specimen into the T2 MRI images will be evaluated.
Secondary outcome
The secondary endpoint of the study is the correlation of the tumor extend in
uterus and parametria on MRI and microscopic images.
Background summary
Radiotherapy plays an important role in the treatment of loco-regional cervix
cancer. Guidelines for radiation prescribe the following radiation targets: The
whole uterus including corpus, cervix and parametrium on both sides, and pelvic
lymph nodes. Irradiating the whole uterus including a margin for its possible
positions in multiple fractions of radiotherapy results in a large treatment
field including small bowel and bladder as organs at risk. This in turn results
in side effects like nausea, vomiting and fibrosis. Reducing the irradiated
volume by excluding the fundus of the uterus in selected cases would decrease
the severity and occurrence of the side effects. For this, better pretreatment
knowledge on the extend of the primary tumor is needed. MRI seems a promissing
tool for assessing the extend of the primary tumor but has not been validated
yet. Furthermore DWI and DCE seems to be useful for this purpose next to the
regular T2 weighted images in MRI.
Study objective
The objective of this study is to investigate the faesibility to fuse images of
patholocial anatomy after uterusextirpation according to Wertheim-Okabayashi
into tyhe pre-operative T2/DWI/DCE weighted MR images using non-rigid
co-registration.
Study design
A prospective observational feasibility study.
Study burden and risks
The burden is minimal; patients participating have to visit the hospital once
to undergo the MRI-scan with gadolinium contrast with the usual T2 weighted
imaging and de extra added DWI and DCE; maximally two weeks preoperatively. The
scan usual scan lasts 15 minutes, the extra imaging takes account for an extra
20 minutes of scanning. Few patients can experience a headache or nausea due to
the gadolinium. Some patients with claustrophobia may experience fear.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with a carcinoma of the cervix for whom a Wertheim surgical procedure is planned. They must be older than 18 years of age and have a WHO status of 0 or 1.
Exclusion criteria
Exclusioncirteria are MRI related. Patients with claustrophobia, a pacemaker, medicine pump, neurostimulator, cochlear implants, other metal implants in the pelvis wich would disturb the image. In some cases surgical clips in the brain are contra-indicated, this will be evaluated conform standard protocol. Patients with a GFR < 30 ml/min/1,73 m² wil be excluded.
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 | NL39945.018.12 |