The primary objective of this study is to investigate the capability of diffusion weighted magnetic resonance imaging (DWI) to assess tumor resectability after FOLFIRINOX, compared to standard CT scan.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: correct assessment of tumor resectability according to
DWI MRI, compared to standard CT.
Secondary outcome
Active tumor size on MRI and CT will be compared, and in patients receiving
resection also compared to the active tumor size in the resected pathology
specimen.
Background summary
Pancreatic cancer is the fifth leading cause of cancer-related death in the
Netherlands. Approximately 40% of patients present with locally advanced, i.e.
unresectable, pancreatic cancer (LAPC). Standard chemotherapy in these patients
offers only a limited survival benefit. With the improved FOLFIRINOX
chemotherapy, various studies, including from our own center (the IMPALA study,
NL44713.018.13), demonstrate that in a substantial proportion of patients
(10-20%) the tumor is downstaged to such an extent that it becomes eligible for
resection. Unfortunately, current standard computed tomography (CT) imaging is
extremely inaccurate to determine resectability following FOLFIRINOX
(specificity 0-50%). With better imaging, patients could be better stratified
for curative or palliative treatment options.
Study objective
The primary objective of this study is to investigate the capability of
diffusion weighted magnetic resonance imaging (DWI) to assess tumor
resectability after FOLFIRINOX, compared to standard CT scan.
Study design
Monocenter cohort study
Intervention
MRI scan with diffusion weighted imaging (DWI)
Study burden and risks
the risks associated with administration of contrast fluid and placement of an
intravenous line are minimal
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with locally advanced pancreatic cancer, without distant metastases, after 2 months of FOLFIRINOX chemotherapy undergoing explorative laparotomy
Exclusion criteria
Contra-indications for MRI
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 | NL56565.018.16 |