Detection of loco-regional invasion of cervical cancer with 7 Tesla MRI

In the Netherlands, the absolute incidence of cervical cancer is approximately
720 patients per year, with an overall mortality of 28.6%. The accurate
assessment of local cervical cancer spread (i.e. invasion) is of clinical
importance for staging and treatment considerations. For example, if
parametrial invasion is absent, radical surgery is the treatment of choice for
tumors less than 4cm in diameter. However, if such invasion is present, the
patient has become inoperable and (chemo)radiotherapy is warranted.
Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited
accuracy for detecting loco-regional tumor invasion. Due to relatively frequent
false-negative findings a risk of understaging and under-treatment occurs. For
such cases adjuvant treatments with (chemo)radiotherapy are indicated after the
initial surgery, causing increased morbidity and treatment associated risks.
For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based
delineation of local tumor spread could enable individualized dose(volume) and
field modifications.

To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which
use a combination of an endorectal and external coil, to image the
(para)cervical area for assessment of the loco-regional tumor status in
cervical cancer.

The proposed study is an investigator initiated, single center, prospective
pilotstudy. The 7T MR Imaging in cervical cancer patients is added to unaltered
clinical care. Treatment(choices) is/are not part of the study, the physician
will perform standard clinical care.

Subjects partaking in this study will not directly benefit from their
participation.

Ultimately, in case of a positive study outcome, future patients may benefit
from a ultra high field MR Imaging protocol developed by this study. Hence,
participation is on an altruistic basis. Standard clinical care is given
regarding the staging work up, with the 7T MRI added. The additional risks are
considered negligible for the subjects. Standardized UMC Utrecht 7T MRI
checklists will be in effect to ensure that no subject with a contra-indication
to 7T MRI is scanned. This includes a urine pregnancy test in premenopausal
women. This study does not prescribe the use of medication or any MRI contrast
agent. The use of an endorectal coil (i.e. antenna) may yield feelings of
embarrassment, but is not painful or dangerous. Single use, sterile catheters
will cover the antenna during insertion. The study protocol is specifically
designed for safe and hygienic use of the coil as well as to maximize the
subject*s sense of privacy. The images created by 7T MRI will not be reviewed
in a regular clinical fashion, however, incidental findings are reported to the
treating physician. The treating physician is unrestricted in his/her treatment
possibilities.