Real-time lesion targeting during MR-guided prostate biopsy using an iPad: a pilot study

Prostate cancer (PCa) is the most diagnosed non-skin cancer in men in the
Netherlands. Population aging and wider spread use of prostate-specific antigen
(PSA) screening tests are expected to further increase diagnosis of this
disease. In case of an elevated PSA, systematic transrectal ultrasound
(TRUS)-guided prostate biopsy is currently the standard technique to detect
PCa. However, as PSA is a non-specific marker for prostate cancer, urologists
are increasingly confronted with the dilemma of seeing patients with a high
clinical suspicion of PCa but negative initial TRUS-guided biopsy results. More
recently, the use of multi-parametric MR imaging has been well established in
detecting PCa, showing high localization accuracy. Consequently, MR imaging has
also been proposed in guiding biopsies towards cancer suspicious regions, with
the aim of improving diagnostic performance. MR-guided prostate biopsy is
routinely used in clinical practice at this institution. Nevertheless, an
important limitation of this procedure are long procedure times, mainly due to
the time-consuming process of lesion targeting. We devised a method for
real-time lesion targeting during MR-guided prostate biopsy using an iPad
inside the MR-room.

The purpose of our study is to prospectively establish in vivo in patients
proof of principle for real-time lesion targeting during MR-guided prostate
biopsy using an iPad inside the MR-room. Additionally, we will evaluate the
time to first biopsy and total procedure time of MR-guided prostate biopsy with
and without real-time lesion targeting against a matched patient cohort.

Prospective, non-randomized, single centre pilot study

All subjects will undergo MR-guided prostate biopsy with real-time lesion
targeting

Patients will undergo MR-guided prostate biopsy in a single session, as is
routine clinical practice, placing no increased burden on the patients. Most
important potential risk of the study would be unwanted attraction of the iPad
to the MR scanner, causing injury to the patient or operator. In-house safety
tests have been performed to determine safe limits in which the iPad can be
used inside the MR-room. This will be safeguarded by marker indications placed
inside the MR-room and mounting of the iPad to an MR-compatible IV pole to make
sure it is secured at all times. Also, the MR-compatible IV-pole will be
securely attached to the wall or MRI scanner table to prevent it from falling.
Furthermore, we will have an additional researcher be present during all biopsy
procedures who is charged with ensuring and safeguarding the safe working
environment within the MR scan room. With these safety measures, no additional
risk to the patient or operator is expected. Also, no increased risk is
expected with regards to diagnostic performance of the biopsy procedure as a
standard confirmation scan according to the current standard clinical protocol
will be obtained before each actual biopsy is taken and, if required, the
needle guide is adjusted to ensure accurate sampling of the target region. Most
important potential benefit for patients could be faster procedure time,
reducing the time the patient has to lie inside the MR scanner and, thereby,
patient discomfort.