Compare clinical investigation with different high-resolution MR imaging protocols in the preoperative assessment of patients with vulva carcinoma.
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tumor dimensions and sensitivity and specificity of determination of
locoregional invasion.
Secondary outcome
n.a.
Background summary
High-resolution MRI may provide valuable additional information in patients
with vulva carcinoma, especially in regard to the surgical work-up.
Study objective
Compare clinical investigation with different high-resolution MR imaging
protocols in the preoperative assessment of patients with vulva carcinoma.
Study design
Prospective pilot study.
Study burden and risks
Normally these patients receive a CT scan before the operation. When they
participate to the study a MRI scan will be done in staed of a CT scan.
's Gravendijkwal 230
3015 CE
Nederland
's Gravendijkwal 230
3015 CE
Nederland
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Histologically-proven squamous cell carcinoma of the vulva
- Clinical planning includes radical local excision of vulva carcinoma
- informed consent
Exclusion criteria
- Tumor-urethra, tumor-anal canal, or tumor-vagina distance > 2 cm (these
patients are excluded as the chance of locoregional invasion is too low)
- Contraindications for MRI (including claustrophobia, obesity preventing
placement in MR scanner, metal in body, *)
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 | NL24742.078.08 |