To determine the diagnostic performance and potential clinical benefit of DW-MRI as a staging tool to identify patients with advanced stage ovarian cancer who can benefit from cytoreductive surgery.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic performance of DW-MRI to predict whether complete cytoreductive
surgery can be achieved (defined as the number of cytoreductive procedures
correctly predicted by DW-DWI).
Secondary outcome
- Diagnostic performance of radiological Peritoneal Cancer Index (rPCI)
determined DW-MRI to predict surgical Peritoneal Cancer Index (sPCI).
- Inter-observer agreement between different readers for DW-MRI.
- Diagnostic performance of radiological Peritoneal Cancer Index (rPCI)
determined CT to predict surgical Peritoneal Cancer Index (sPCI).
- Comparing the performance of CT and MRI.
- Number of additional *second look* surgical findings due to the per-operative
availability of DW-MRI findings
- Incremental costs, effects, and incremental cost-effectiveness ratio
Background summary
Cytoreductive surgery (CRS) is the treatment of choice for peritoneal
carcinomatosis (PC). In order to achieve a significant survival gain a complete
cytoreduction is essential in the surgical treatment of PC in advanced stage
ovarian carcinoma. Whether a complete cytoreduction is feasible is determined
by the amount and localization of disease in the abdomen. In ovarium carcinoma
the Peritoneal Cancer Index (PCI) is a scoring system using surgical inspection
to assess the amount and localization of disease. This scoring system is used
similarly in PCs of other origins, such as colorectal cancer. Currently a
diagnostic laparoscopy is often used to inspect all areas in the abdomen and to
predict whether a complete cytoreduction is feasible. However, with this
invasive procedure it is not always feasible to inspect all relevant areas in
the abdomen due to the presence of adhesions and / or tumor. It would therefore
be more than helpful if a radiological diagnostic tool could accurately assess
the amount and localization of peritoneal disease before any surgery in order
to predict the possibility of achieving a complete cytoreduction. Thus far, the
accuracy of the radiological diagnostic tools remains limited. A better
selection of the group of patients in whom a complete cytoreduction is feasible
will limit the number of ineffective procedures; for patients with advanced
stage ovarian carcinoma a better diagnostic tool will enable the clinician to
decide whether to perform primary cytoreductive surgery or start with
neo-adjuvant chemotherapy.
However, current radiologic diagnostic tools are not able to accurately predict
the PCI and therewith the chance of performing complete cytoreductive surgery.
The most commonly used diagnostic tool is CT, which is known to have limited
accuracy in demonstrating the extent of peritoneal seeding. A recent
meta-analysis showed a poor pooled sensitivity of 73% for the detection of
peritoneal seeding on a patient basis[1].
The superior soft tissue contrast of magnetic resonance imaging (MRI) makes
this technique very promising for evaluating peritoneal involvement. An added
benefit of MRI is the addition of diffusion-weighted sequences. Diffusion
weighted imaging (DWI) is a powerful functional imaging tool for the detection
of even small-volume malignant disease. Recently, DW-MRI has shown to be
superior to CT in predicting incomplete resection and staging in patients
suspected of having ovarian cancer[2]. A few small studies showed improved
results in predicting PCI with MRI[3, 4]. Despite these promising results, the
role of MRI for staging the peritoneal cavity has not been extensively studied
thus far.
Study objective
To determine the diagnostic performance and potential clinical benefit of
DW-MRI as a staging tool to identify patients with advanced stage ovarian
cancer who can benefit from cytoreductive surgery.
Study design
Prospective observational cohort multi-center study.
Study burden and risks
MRI is a standard diagnostic procedure without the use of radiation. The MR
sequences, MR-contrast agents and Buscopan (to mimimize peristaltic bowel
movements) are all commonly used in daily clinical practice. The only extra
burden will be that patients will be asked to drink 1L of pineapple juice 1h
before the MRI (to minimize signal in the bowel lumen and optimize image
quality), which is standard procedure in many clinics for MRCP and MR
enterography.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
- Age >18 years
- Written informed consent
Exclusion criteria
Patients with contraindications for MRI:
- Patients who have a heart pacemaker may not have an MRI scan
- Patients who have a metallic foreign body (metal sliver) in their body
- Patients with severe claustrophobia
- Contrast allergy for MRI contrast agent Gadolinium (extremely rare)
- Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2)
- Ineligibility to receive Buscopan
- Allergy for pineapple juice and blueberry juice.
Patients with contraindications for CRS
- WHO performance status 3 or higher
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 |
|---|---|
| ClinicalTrials.gov | NCT03399344 |
| CCMO | NL63521.031.17 |