The aim of the study is to prospectively evaluate the accuracy of integrated whole body positron emission tomography/computed tomography (PET/CT) in staging patients with primary ovarian cancer, with use of histological findings as the reference…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in ovarian carcinoma stage
according to the International Federation of Gynecology and Obstetrics (FIGO),
based on PET/CT and surgery/histological findings.
Secondary outcome
niet van toepassing
Background summary
Combined PET/CT has been shown to be superior to other imaging modalities in
most tumor types. However current data on the use of combined PET/CT for
staging primary ovarian cancer is limited. If combined PET/CT turns out to be
a reliable modality for assessing the extent of disease in patients with
primary ovarian cancer, tumor and metastases can be better localised and
excised and the amount of unnecessary surgical interventions (such as
lymphadenectomy) and its complications can be reduced.
Study objective
The aim of the study is to prospectively evaluate the accuracy of integrated
whole body positron emission tomography/computed tomography (PET/CT) in staging
patients with primary ovarian cancer, with use of histological findings as the
reference standard.
Study design
observational pilot study
Study burden and risks
niet van toepassing
p debeyelaan 25
6229 HX Maastricht
Nederland
p debeyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
age > 18 years and suspicion of primary ovarian cancer based on the results of complaints, physical examination and findings from ultrasound
Exclusion criteria
pregnancy, unwillingness to give informed medical consent, evidence of significant psychiatric disorder by history or exam, previous pelvic-abdominal surgery, radiotherapy within six months of study entry or chemotherapy.
Design
Recruitment
Medical products/devices used
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 | NL12219.068.06 |