To optimize DCE-MRI, T2* MRI and DWI in pancreatic cancer at 3T and investigate its reproducibility.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reproducibility of MRI parameters.
Secondary outcome
Correlation of MRI parameters with histology.
Background summary
Novel predictive markers are needed to determine treatment efficacy in
pancreatic cancer at an early stage. Preferably, these markers could be
determined non-invasively and provide insight into the biology of pancreatic
cancer. Several MR techniques can serve for this purpose. However,
optimalisation of these techniques is needed and their reproducibility should
be assessed.
Study objective
To optimize DCE-MRI, T2* MRI and DWI in pancreatic cancer at 3T and investigate
its reproducibility.
Study design
In the first part of the study, patients with pancreatic cancer will undergo an
MR measurement protocol once at 3T, to optimize MR techniques (DCE-MRI, T2* MRI
and DWI). In the second part of the study, to assess reproducibility patients
will undergo the MR measurement protocol twice within one week before start of
any treatment.
Study burden and risks
Participation mainly concerns a time investment (60 min for the optimalisation
part of the study and 2x45 min for the reproducibility part of the study).
Administration of contrast agent is associated with a small risk on an allergic
reaction. Administration of Buscopan may cause adverse effects.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
* Any tumor with a size * 1cm
* WHO-performance score 0-2
* Written informed consent
Exclusion criteria
* Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
* Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia.
* Renal failure (GFR < 60 ml/min) hampering safe administration of a double bolus of Gadolinium containing MR contrast agent.
* For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MRI scanning.
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 | NL40501.018.12 |