To determine the feasibility of Fusion MRI-ultrasound for the uterus and ovary.To determine if Fusion MRI-ultrasound is more accurate for the diagnosis of endometiosis then MRI or ultrasound alone.
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pilot:
Is calibration feasible in gynecological patients?
Study:
correlation between fusion MRI-ultrasound and conventional MRI and between
conventional ultrasound.
Secondary outcome
none
Background summary
Endometriosis is defined as the presence of endometrial glands and stroma at
extra uterine sites. Prevalence is estimated at 5-10% in women of reproductive
age and up to 50% in women with infertility. The average time from the first
symptoms until the diagnosis of endometriosis is 7-8 years.
Patients with endometriosis and a frozen pelvis and/or nodules in the bowel
and/or nodules in the bladder are best managed in a multidisciplinary team. A
correct diagnosis of endometriosis is necessary.
Transvaginal ultrasound and Magnetic Resonance Imaging both have advantages and
disadvantages. Fusion MRI-ultrasound may be more accurate in the diagnosis of
endometriosis and hopefully reduce the time between the first symptoms and
diagnosis.
Study objective
To determine the feasibility of Fusion MRI-ultrasound for the uterus and ovary.
To determine if Fusion MRI-ultrasound is more accurate for the diagnosis of
endometiosis then MRI or ultrasound alone.
Study design
Pilot:
Inclusion of 10 patients with a MRI for a benign disease. Within 3 weeks of the
MRI a transvaginal ultrasound according to the fusion protocol will be
performed: first, the MRI and ultrasound will be calibrated. Then, a few
anatomical landmarks will be chosen (cervix, urethra, rectum, ovary) and the
distance from the landmark to the calibrationpoint will be measured. After 5
minutes, the measurement will be repeated to determine the reproducibility.
Study:
Inclusion of 25 patients with a MRI for endometriosis preoperatively. Within 3
weeks of the MRI scan a transvaginal ultrasound according to the fusion
protocol will be performed. Calibration as above. Then, every spot suspected
for endometriosis on conventional ultrasound or MRI will be reassessed:
endometriosis yes/no.
Study burden and risks
1 extra visit to the outpatient clinic. During that visit a transvaginal
ultrasound will be performed.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Pilot 1: patients who need a MRI for a benign illness (no. 10)
Pilot 2: patients who need a MRI for endometriosis (no. 25)
patients age >18 years
Exclusion criteria
Patients under the age of 18 years
patients with a contraindication for a MRI scan
patients who are unable to have a transvaginal ultrasound
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL48237.098.14 |