Per-procedural ablation zone imaging with MRI during radiofrequency ablation of locally irresectable pancreatic cancer

In the PELICAN-trial the benefit of intraoperative local radiofrequency
ablation (RFA) therapy of irresectable locally advanced pancreatic cancer
(LAPC) is investigated in a randomized multicenter phase III clinical trial.
Intraoperative RFA of LAPC has been shown to be feasible and safe, but
temperature feedback during the ablation procedure is currently lacking.
Therefore, the extent of ablation has to be estimated based on modeling and
phantom studies and intraoperative assessment of treatment efficacy and
complication risks is limited. Intraoperative MR imaging of RFA therapy could
provide MRI temperature feedback allowing real-time monitoring of the ablation
process and enable delineation of the true ablation zone following RFA therapy.

To assess the feasibility of real-time MRI temperature monitoring and ablation
zone assessment during RFA of LAPC.

Prospective, non-randomized, single centre pilot study.

Patients will undergo intraoperative MR imaging while under general anaesthesia
for the exploratory laparoscopy procedure performed within the PELICAN-trial.
The addition of intraoperative MR imaging is therefore expected to place no
direct increased burden on the patients. However, total procedure time and
anaesthesia time may be longer due to transfer of the patient to and from the
MRI suite, which is anticipated at approximately 30 minutes. Most important
risk of the study would be unwanted attraction of metallic objects to the
magnet, which may be introduced to the MRI environment upon patient transfer.
Such an event would pose hazard to the patient and/or clinical staff members
present in the MRI room. To ensure proper management of these risks, an MRI
safety protocol was established. A safety checklist will be used during all
procedures to ensure all safety measures have been taken correctly before
patient transfer is commenced. Also, one staff member will be charged with
ensuring and safeguarding the safe working environment within the MR scan room
and is required to be present during all procedures. With these safety
measures, no additional risk to the patient or operating team is expected. Most
important potential benefits of intraoperative MR imaging during the RFA
therapy are that per-procedural complications may be avoided by monitoring of
temperatures near adjacent structures-at-risk as well as the ability to
visualize the zone of effective treatment, which may hold predictive value for
therapy response and patient prognosis.