To validate MRI for assessing craniocaudal tumor extension with histopathology using non-rigid egistration. In addition to 3 Tesla magnetic resonance T2-weighted imaging, diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) imaging…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Craniocaudal primary tumor extension in direction of the uterine fundus on T2
weighted 3T MRI enforced with DWI/DCE compared to histopathology.
Secondary outcome
To establish the correlation of T2 weighted MRI enforced with DCE and DWI with
the microscopic tumor extent in uterine cervical cancer in uterus and
parametrium.
Background summary
Radiotherapy plays an important role in the treatment of loco-regional advanced
uterine cervical 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 both short term and long term side effects like
radiation enteritis and cystitis, nausea and fibrosis. Reducing the irradiated
volume by excluding the fundus of the uterus would decrease the severity and
occurrence of the side effects. For this, better pretreatment knowledge on the
extent of the primary tumor is needed. The previously conducted feasibility
study proved its feasibleness.
Study objective
To validate MRI for assessing craniocaudal tumor extension with histopathology
using non-rigid egistration. In addition to 3 Tesla magnetic resonance
T2-weighted imaging, diffusion weighted imaging (DWI) and dynamic contrast
enhanced (DCE) imaging will be added with the intention to proceed to a
prospective observational study to establish the macroscopic and the
appropriate margin to cover for microscopic tumor in uterine cervical cancer on
MRI. Furthermore a CT of the resected uterus will be needed to facilitate
non-rigid registration.
Study design
A prospective observational study of validation. Patients who participate in
this study will undergo a preoperative T2/DWI/DCE MR scan. After the
Wertheim-Okabayashi surgical procedure a CT-scan of the uterus will be made.
Treatment protocols are based on routine clinical assessment, MRI and
histopathology and not altered after the fusion of MRI and histopathology.
Study burden and risks
The burden is minimal; patients participating have to visit the hospital once
to undergo the usual T2-weighted MRI added with an extra sequence for DWI and
DCE; maximally two weeks preoperatively. The scan will take an additional 20
minutes with the usual 30 minutes. Furthermore gadolinium based contrast will
be administered, patient at risk for nephropathy will be excluded. No
additional side-effects or risks have been reported on MR imaging, some
patients may experience claustrophobia.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
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 | NL59623.018.16 |