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14 A History of Reporting Standards for Prostate Magnetic Resonance Imaging: PI-RADS, PRECISE…
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Employing aQuality Improvement Program toOptimize mpMRI-Directed Fusion Biopsy
MahdiMottaghi, MichaelC.Ivey, SriramDeivasigamani, andRajanT.Gupta
Denition ofQuality Improvement
For any given procedure, there are multiple lay­ers of quality management to achieve better out­comes. “Quality control” refers to a process of assessment and identication of deviations from acceptable ranges and trying to rectify them. It is considered a reactive, remedial tool that acts after an error has happened. A more developed approach, “quality assurance,” is a closed-loop, retrospective process that aims beyond conrm­ing the expected function toward achieving better results. This systematic approach involves metic­ulous data collection and evaluation, often com­ing into effect after an error has occurred; namely, it includes quality control but also aims to pre­vent future recurrences (Fig. 15.1). However, a more dynamic, proactive strategy called “Quality Improvement (QI)” involves a systematic analy­sis of processes and outcomes to proactively identify areas for enhancement; thus, it could be retrospective or prospective but should be intro­spective. QI should function as a mechanism to guarantee the delivery of high-quality healthcare
M. Mottaghi · M. C. Ivey · S. Deivasigamani · R. T. Gupta (*) Duke Cancer Institute and Duke University Medical Center, Durham, NC, USA e-mail: mahdi.mottaghi@duke.edu;
michael.c.ivey@duke.edu; sriram.deivasigamani@duke.edu; rajan.gupta@duke.edu
15
Fig. 15.1 Quality Control: Is the system/process func-
tioning as intended? Quality Assessment: In the event of an error, how can it be preemptively avoided? Quality Improvement: Proactively strives for enhancement before the occurrence of errors
to patients, concurrently emphasizing the itera­tive renement of optimal system performance standards [1].
Institutional Workow
The cornerstone of fusion biopsy QI lies in the interdisciplinary communication among the radiologist, urologist, and pathologist. As the procedure is operator-dependent and technol­ogy-intensive, having an adept nurse/technician with a urologist at the time of the procedure is helpful and could potentially decrease errors. As an example from Duke University Hospital, FB workow begins with MRI acquisition, interpre­tation, structured reporting, MR segmentation (contouring prostate margins), and outlining the region of interest (ROI) by a dedicated abdominal radiologist. At the time of the biopsy and joined
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024 T. J. Polascik et al. (eds.), Imaging and Focal Therapy of Early Prostate Cancer,
https://doi.org/10.1007/978-3-031-66754-1_15
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by a nurse/technician well- versed in the FB pro­cedure, an experienced urologist reviews the MRI ndings, proceeds to transrectal ultrasound (TRUS) acquisition (sweeping the US slowly to generate a 3D prostate construct) and ultrasound segmentation (marking prostate boundaries), executes MRI- ultrasound registration/fusion, obtains targeted biopsies, and labels each core before sending them to the pathology ward [2].
As a part of the QI protocol, the radiologist and urologist convene routinely in person and collectively examine the imaging for specic patients before the biopsy to discuss gland seg­mentation, lesion eligibility, prioritization, and segmentation. This provides an additional step of planning, with the main goal of establishing a mutual understanding of the MRI target(s) and how they translate for procedure planning. The second goal of this session is to resolve discor­dant biopsy results from the previous cases with the inclusion of the pathologist. Additional ben­ets are ensuring the suitability of the patient for FB, using the same nomenclature, providing a structured radiology and pathology reporting for-
mat, and allowing clinically relevant education for the junior team members. This will help not only the multidisciplinary team but also each dis­cipline to recognize areas of limited understand­ing and integrate this knowledge for better outcomes in the future. When several radiologists within a practice interpret mpMRI, it is advisable to periodically conduct this practice collabora­tively as a group; this approach facilitates collec­tive learning from any identied mistakes or discrepancies. Closed-loop feedback in a two­way fashion allows for mutual learning and improvement, as well as identifying potential areas for enhancing the procedure. Establishing robust professional connections with colleagues in allied specialties associated with prostate can­cer is likely to facilitate open and constructive discussions of this nature. With this institutional example in mind, we now review and discuss the opportunities for QI in FB, from the pre­procedural visit and the biopsy session to recon­ciling discordant biopsy results. A summary of the workow is provided in Table15.1, followed by a detailed discussion of each step.
Table 15.1 Summary of institutional workow with a brief description
Steps in the workow Description
1. Setting realistic expectations and preparation
2. MRI acquisition, interpretation, and reporting
3. Lesion eligibility and prioritization
4. MR segmentation – Marking the boundaries of the prostate and lesion(s) on T2-weighted MRI images
5. Review of MRI data – Import MRI data into the fusion device and review segmentation and MR targets
6. Field generator placement and TRUS acquisition
7. US segmentation – Mark prostate boundaries on multiple axes/views (axial, sagittal, coronal)
8. Registration/fusion – Align the MRI and US prostate and lesion borders and fuse (x) them when the
– Mention the limitations and probable need for repeat biopsy, repeat imaging, and
surveillance
– Provide a list of anticipated complications with instructions to minimize confusion
and anxiety
– Ensure high-quality image acquisition through the use of standardized and validated
imaging protocols as well as the presence and engagement of experienced and highly capable MR technologists
– The expertise of a radiologist(s) interpreting the MR imaging is a crucial factor in a
successful QI program
– Structured radiology reports yield more comprehensive and integrated information – The dominant lesion is dened as the lesion with the highest PI-RADS score
– If multiple lesions have the same PI-RADS score, priority at the time of sampling is
generally given to the largest lesion
– If multiple lesions share the same score and size, preference is given to the one
demonstrating features of extra-prostatic extension
– Placing the eld generator near the patient and ensuring that the prostate, grid, and the
US probe are in range
– Perform TRUS with a steady and even sweep to obtain prostate images
appropriate overlap is achieved
(continued)
15 Employing aQuality Improvement Program toOptimize mpMRI-Directed Fusion Biopsy
Table 15.1 (continued)
Steps in the workow Description
9. Patient factors during FB
10. Biopsy – Utilize fusion software for precise target navigation, correlating natural landmarks
11. Reverse fusion – The multidisciplinary review of discordant pathology results of FB by re-evaluation of
– Provide a relaxing environment – Familiarizing the patient with the sound of the biopsy device
through real-time US
– It is important to rapidly complete the procedure to minimize patient discomfort
imaging and lesion sampling
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Setting Realistic Expectations andPatient Preparation
In the current age of technology and communi­cation, individuals frequently engage in online research before scheduling appointments with doctors, particularly when confronted with the daunting term “cancer.” Patients usually learn about the benets of FB as an advanced technology- intensive technique compared to systematic TRUS biopsy. While this is accurate, individuals may have relatively heightened expectations of FB outcomes [3]. It is crucial to communicate the potential limitations of the technique and equipment to the patient in an effort to maintain trust in the patient-physician relationship. Patients must understand that mpMRI helps to improve localizing the lesion, but it is not perfect, and repeat FB, repeat imag­ing, or surveillance might be the next steps [4,
5]. Patients should also receive standard pre-
operative instructions (the need for pre-biopsy urinalysis, holding blood thinners, pain killers, and herbal supplements with appropriate con­sultation, the importance of prophylactic antibi­otics, rectal preparation with enema or suppositories, etc.). Because the patient might be in pain and has lower tolerance on the day of the biopsy, providing a list of anticipated adverse events at the pre-biopsy visit, along with concise tips for self- management of mild complications, instills a sense of reassurance and mitigates anxiety. Equally essential is pro­viding emergency contact information for more severe complications. Patient-specic counsel­ing is also helpful. For example, men with larger prostates have higher chances of developing uri­nary retention and infectious-related hospital-
ization [6]. Sampling periurethral lesions, especially in mid-gland TZ, has a higher likeli­hood of post-FB hematuria and urinary retention.
Healthcare providers should bear in mind that a signicant proportion of the mentioned patients may need repeat biopsies for various reasons. Establishing and fostering patient trust will con­tribute to delivering enhanced care in subsequent stages of management.
MRI Acquisition, Interpretation, andReporting
The diagnostic pathway of PCa detection has changed in the last decade, and several well­designed trials strongly recommend mpMRI acquisition before biopsy [7, 8]. High-quality MR images are important to accurately detect, biopsy, and stage clinically signicant PCa (csPCa) and, ultimately, to appropriately select patients for focal therapy (FT) or direct them to another management plan. The expertise of the radiologist(s) is a pivotal determinant in the effectiveness and success of a QI program by enhancing the program’s ability to identify, address, and implement improvements in diag­nostic processes, ultimately leading to more pre­cise targeting and enhanced patient outcomes and quality of care. Structured radiology reporting is another important factor that can yield more comprehensive and integrated information and minimize confusion between the radiologist cre­ating the report and the urologist reading that report. A detailed description of the technical parameters of mpMRI and protocol, mpMRI quality assessment (PI-QUAL), and Prostate
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Imaging Reporting and Data System (PI-RADS) determination and interpretation is discussed in the previous chapter as high-quality MR image acquisition is at the core of this imaging-based strategy.
Lesion Eligibility andPrioritization
Following image acquisition, the subsequent crucial step involves identifying areas deemed suspicious for biopsy. To get the most yield from histological examination, several factors should be considered, like the level of suspicion on mpMRI (PI-RADS), lesion size, and distance from the prostate capsule (possibility of extra­prostatic extension). The dominant lesion is characterized as the lesion exhibiting the high­est PI-RADS score. Similar to evidence from high- volume centers [9], in our institutional analysis involving 392 patients with a total of 521 lesions that were biopsied with a single urologist with more than 11years of experience with FB, the positive predictive values (PPV) for PI-RADS 5, 4, and 3in detecting any PCa and csPCa were determined to be 0.80, 0.55, and 0.24, and 0.63, 0.33, and 0.09, respectively [5]. Even though the PI-RADS system is not perfect and continues to be iterated to ensure its continued strong diagnostic performance, the degree of suspicion for clinically signicant prostate cancer has been a predictor of FB suc­cess, and the latest PI-RADS version (2.1) pro­vides higher PPV, especially for lesions originating in the TZ [9, 10]. Some studies pro­posed that in addition to the PI-RADS score, accounting for patient characteristics (i.e., age, PSA density, history of prostate biopsy, race, and family history) could yield a better assess­ment of suspicion and csPCa detection, espe­cially for PI-RADS 3 and 4 lesions [1114].
Tumor volume could be considered another predicting factor for detecting a csPCa follow­ing FB. In cases where multiple lesions share the same score, the largest lesion or the one demonstrating indications of extra-prostatic extension is chosen to be prioritized at the time
of targeting/biopsy. Based on our institutional experience, lesions lower than 0.2mL could be targeted successfully by an experienced team, but a lower tumor volume on mpMRI is corre­lated with a lower likelihood of csPCa detection [15, 16].

MR Segmentation

MR prostate segmentation is done by using T2-weighted imaging, usually in the axial plane, as it is the highest resolution anatomic sequence in prostate mpMRI.Then, the lesion boundaries are selected from neighboring slices to form a 3D lesion for targeting. The process is done mostly manually, and the operator is usually a radiologist or, in certain cases, the urologist. The manual process is operator-dependent and can be time- consuming, and there is growing interest in the incorporation of AI-based methodology for a more precise, time-sensitive prostate seg­mentation [17]. Some articles suggest perile­sional biopsies to account for variations in determining the target-lesion boundaries [18]. Any inaccuracies occurring at this phase result in subsequent errors in the procedure. One of the main steps during MR segmentation is marking the boundaries of anterior bromuscular stroma (AFMS). Despite the distinct AFMS margins on mpMRI, it is hard to dene a sharp anterior bor­der via the US during the procedure (Fig.15.2). Additionally, the apex of the prostate is fre­quently indistinct in the US due to anatomical variations (Fig.15.3), and the prostate base may pose challenges due to the presence of an intra­vesical or irregularly shaped median lobe [19]. It is imperative to perform MR segmentation with consideration for US limitations during the biopsy.
In practical situations, uncertainty may arise in contouring, requiring decisive judgment based on the individual’s expertise. In situations where the urologist is not the individual conducting the MR segmentation, understanding and communi­cating these operator-dependent decisions are paramount to achieving optimal results.
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15 Employing aQuality Improvement Program toOptimize mpMRI-Directed Fusion Biopsy
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a
Fig. 15.2 Margin of AFMS is evident on MRI due to the higher tissue contrast between the AFMS and the adjacent prostate tissue/periprostatic fat (a), while it is harder to distinguish it on US (b)
a
b
b
Fig. 15.3 Variations of apex view on sagittal US.Anterior apex can overlap the membranous urethra (a, b). Similar variation is possible for the posterior apex (a, c). No over­lap is also possible (d). (The image is reused with permis-

US Segmentation

sion: Park, J.S., Lee, D., Koo, K.C., et al. The role of prostatic apex shape in voiding symptoms and urine ow: an exploratory and conrmatory study. World J Urol 38, 1275–1282 (2020), Springer Nature)
TRUS starts with a slow sweep of the probe (which could be craniocaudal or from side to side
The eld generator (or electromagnetic tracker) keeps track of the grid, probe, and needle trajec­tory during the procedure. It must be positioned in a location that sufciently covers the biopsy eld and tracks the needles in 3D space. The US probe should be covered with an endocavity balloon, which is already lled with 10–20mL of US gel, in a way that no air remains within the balloon to avoid artifacts during the procedure.
based on the platform), and 3D construction of the prostate is built from a series of 2D slices. US segmentation should be done with consideration of MR segmentation. For instance, if a protruded intravesical median lobe is evident in the US but is not marked in the MR segmentation, the del­ity of the resultant fusion will be impaired. The platform we use in our institution can record this stage (upon clicking on the recording button)
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through the end of the biopsy. This will be help­ful in reassessment of the possible errors during the procedure in case of any unexpected results, which will be discussed later in this chapter.
To achieve a steady and even sweep, the urolo­gist can hold the probe with the elbow at 90° and rotate the probe from pronation to supination while keeping the forearm and wrist in a straight line. In cases where the MRI is obtained with an endorectal coil (ERC), the urologist may need to modify the pressure applied by the US probe to align more closely with the observed deforma­tion of the prostate due to the ERC. However, applying disproportionate probe pressure on the prostate should be avoided, as it can lead to dis­placement and deformation of the prostate. Worthy to mention that the lesion can also be dis­located by the inappropriate pressure of US probe and the degree of lesion displacement is higher for the posterior midline lesions (peripheral zone) compared to anterior lesions due to their closer proximity to the probe and rectum [20]. Application of extra pressure on US probe can cause additional distortions in the 3D US con­struct and result in a suboptimal fusion. The urol­ogist should check the shape of the 3D US construct during the US segmentation. Abnormal shapes could be generated due to uneven sweep, calcications, and apex anatomical variation. Adjusting US contrast to get a sharper gland bor­der and repeating the sweep might rectify this error.

MR-US Registration/Fusion

Registration regarding MR-targeted FB refers to the process that involves bringing MRI and US images in spatial alignment. When appropriate alignment is achieved during the procedure, both images are fused together so the urologist can proceed to the lesion targeting. The accuracy of the image registration is crucial for proper target­ing, especially for smaller US-invisible targets and those far from internal ducials (prostate boundaries, urethra, cysts, calcications, etc.). Different platforms that are available for MRI­targeted FB are explained in Chap. 18 of this text-
book by Rais-Bahrami et al. There are two available algorithms for image registration, rigid and elastic, and most of the fusion platforms offer both.
• Rigid registration superimposes 3D MR and US reconstructions based on corresponding borders. The borders are xed (i.e., rigid) for each reconstruction, but their overlay is adjust­able through rotational or translational move­ment of the US image across all three axes.
• Elastic (or non-rigid) registration uses an additional software program to warp the inconsistent borders of MR based on real-time US segmentation during the procedure to pro­vide a better visually registered image.
The apparent malalignments between MRI
and US images by rigid registration led to the development of elastic registration for a more homogenous image. Most of the clinical studies comparing these registration algorithms reported similar efcacy in lesion targeting [21, 22]. Lesion registration error is one of the major reasons for failed FB, and operator experience is likely the main factor, as most of the data used for comparison between the algorithms originated from high-volume centers with experienced staff [23, 24]. Meticulous ne-tuning of the rigid reg­istration, coupled with careful reassessment across multiple planes, can provide the operator with a more comprehensive understanding of the spatial relationship between the target and inter­nal ducials. On the contrary, although elastic registration accommodates variations in prostate deformation caused by factors such as the ERC, US probe, or patient positioning, it also intro­duces additional technical complexity and the possibility of information loss from the MR con­struct. For instance, a phantom study by Pinto etal. showed that lesions near the prostate edge are signicantly more likely higher likelihood of failed FB via the elastic registration [23]. An indicative measure of successful registration is the precision of target alignment when contrasted with visual targeting [2]. A visible lesion on the US that corresponds to the ROI could be a reas­suring sign. QI in using any of the mentioned