In order for DW-MRI to become a possible alternative to invasive diagnostics, we must first optimise the point in the menstrual cycle at which DW-MRI is conducted. This study aims to find the preferable point in the cycle.
ID
Source
Brief title
Condition
- Reproductive tract and breast disorders congenital
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The DW-MRI images will be scored both for quality and for quantity.
Qualitatively, contrast, absence of artefacts, regularity of the image and
overall quality will be scored. Quantitatively, the endometrium thickness,
signal intensity and ADC of the endometrium versus junctional zone and
myometrium will be measured. In addition, the DW-MRI images will be compared to
the conventional T2-weighted images.
Secondary outcome
Not applicable.
Background summary
Infertility and irregular vaginal bleeding are commonly investigated by
invasive assessment of the uterine cavity, like hysteroscopy,
SIS-ultrasonography and HSG. With diffusion-weighted MRI (DW-MRI), a recently
developed MRI technique, a high contrast between the endometrium and myometrium
is seen, thereby creating the possibility for a clear depiction of the shape of
the uterine cavity. This means the diagnostic potential could be equal to the
invasive investigations, and because this investigation is not invasive, it
will have a lower burden for the women who are being investigated.
Study objective
In order for DW-MRI to become a possible alternative to invasive diagnostics,
we must first optimise the point in the menstrual cycle at which DW-MRI is
conducted. This study aims to find the preferable point in the cycle.
Study design
This is a prospective, observational cohort study.
Study burden and risks
The subjects will be scanned three times in one month for 20 minutes. The
questionnaire will take a maximum of 10 minutes. The burden of a single MRI
scan is low, but is higher because of the repeated measurement. In absence of
pacemaker, hearing aid, metal implant or tattoo, there are no known risks
associated with MRI. No MR contrast agent will be administered.
Cambridgelaan 209
3584DZ Utrecht
Nederland
Cambridgelaan 209
3584DZ Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
healthy females with a normal menstrual cycle
Exclusion criteria
use of oral contraceptives or IUD, caesarean section in history, metal implants
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 | NL23509.041.08 |