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Stereo Navigator® PEM‐Guided Biopsy
User Group “Sharing Best Practices” Session
July 13, 2010
Agenda
A. Introduction by Naviscan – Jacqueline Jordan
B. Review of 20 minute biopsy case on MIMViewer™ PEM – Dr. Schilling
C. Sharing Best Practices from the sites – All
D. Discussion of how adding a Lateral Medial view helps better plan biopsy – Drs Schilling and Kalinyak
E. Other comments on how to improve the product and procedure ‐ All
User Group Attendees:
Name Role Facility
Kathy Schilling MD Boca Raton Community Hospital
Sandi Weber RT Boca Raton Community Hospital
Hilary Schwartz RT Boca Raton Community Hospital
Lorry Ponticello RT Boca Raton Community Hospital
Adela Porro RT Boca Raton Community Hospital
Amy Argus MD University of Cincinnati
David Dorfman MD Zwanger‐Pesiri
Gustavo Mercier MD Boston Medical Center
Jim Rogers MD Swedish Cancer Institute
Naviscan Attendees:
Judy Kalinyak, Guillaume Bailliard, Larry Lugo, Ricky Kassab, Linda Ebling, Jacqueline Jordan
A. Introduction by Naviscan
• Reviewed background and timeline of Stereo Navigator release:
1. First‐ever PET‐guided biopsy accessory. PET has never before been utilized to guide any interventional
device in the body before. As such, there is a learning curve for both users and Naviscan as to how the
product is designed and how it is actually used in the field.
2. 510(k) clearance: November, 2008
3. Beta release: April, 2009
4. Full commercial release: June, 2009
• Purpose of the User Group discussion was to share best practices, so that both users and Naviscan can learn
from the group’s collective experience.
• Updated group that Mammotome has received 510(k) clearance for use with PEM using PEM‐guided biopsy
labeling.
• Reviewed 5 steps process as described in User Manual:
1. Initial Biopsy Scan (IBS)
2. Alignment Scan (AS)
3. Pre‐Biopsy Scan (PreBS)
4. Post‐Biopsy Scan (PBS)
5. Specimen Scan (SS)
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B. Review of 20 Minute Biopsy Case on MIMViewer PEM
Boca Raton Community Hospital’s (BRCH) Tips for Reducing Total Procedure Time:
• Procedure was started at 2 h 04 minutes and was completed at 2 h 24 minutes making it a 20 minute case.
Probably could have eliminated the second to last 2 minute image (Pre‐biopsy Scan). Average time is down to
15‐20 minutes.
• One of the most important first steps, just as in MRI biopsy, is for the physician to take a few minutes to review
the conventional imaging in conjunction with the technologists to appropriately position the breast. For
example, if the lesion is inferiorly located, sometimes it is necessary to roll the breast to bring the lesion up into
a more superior location within the breast. “Talking the case out” ahead of time allows everyone to anticipate
what issues may arise and ultimately saves time.
• To reduce the length of imaging time, BRCH has adopted the following practices:
o Alignment Scan is now 2 minutes instead of 4.
o Specimen Scan of petri dish can be done at the same time as the Post‐Biopsy Scan placed on the paddle
adjacent to the breast in the same FOV if one unsure they have the correct tissue. But Dr. Schilling
ultimately prefers a high resolution 4 minute Specimen Scan as well in addition to the scan adjacent to
the breast.
o Routinely eliminate the Pre‐Biopsy Scan (to determine whether lesion has moved or not once the biopsy
tool has been inserted) since she is targeting below the lesion. If targeting underneath the lesion or
towards the floor, the lesion should not move.
o However if you target on the center of the lesion, Dr. Schilling recommends that you do not eliminate
this scan in case of lesion movement.
• Process has been streamlined at BRCH such that the technologists could handle positioning and Dr. Schilling
could enter at the end for 5 minutes to perform the biopsy. However this is not common at their site since Dr.
Schilling takes a more hands on approach.
Positioning Tips for Technologists from BRCH:
• Positioning is the most difficult part of the procedure.
• At their site, it takes 4 hands to position since they need to hold the Posterior Breast Support (PBS) plate on the
other side in place if it is placed at an angle.
• Use PBS plate only sometimes for support.
• To obtain better compression, they often use a Styrofoam pad covered in plastic on the opposite side to push
against the breast instead of the stabilizer rods. The BRCH team also uses them in MR biopsy.
• Sometimes the pad will be used in conjunction with the rods, using the rod to push on the pad and the pad on
the breast.
• For more anterior lesions, BRCH does use the stabilizer rods, mostly flat ones, not the angled ones.
• For implants it is necessary to push the implant back, pushing on the breast to move it anteriorly. Definitely
need 4 hands for such a case.
• For lesions close to the nipple, the angled rod with the pad is helpful, putting pressure on the anterior part of
the breast.
• Use OPSITE™ (Smith & Nephew, London, UK, www.smith‐nephew.com) to wrap the breast on the side closest to
the grid on the posterior side. This provides a barrier between the skin and the grid and prevents patient
pinching on the top and bottom. It also allows better control of the vacuum‐assisted device.
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Case Review on MIMViewer PEM:
• Patient with a small focus of uptake subareolar in the right breast (Figure 1).
Figure 1: PEM CC View of the Right breast showing subareolar uptake
• Typically during a diagnostic scan, a CC and MLO view will be obtained.
• If a patient is going on to PEM‐guided biopsy, they always obtain a lateral medial (LM)/90 degree view to get a
good idea of where the lesion is located in the breast (Figure 2). If they know a patient is going on to biopsy
based on a diagnostic PEM scan, a lateral view may be added immediately after the diagnostic scan. However,
most of the time, a lateral view is done just prior to biopsy.
the lesion in the subareolar position
Figure 2: PEM LM View of the Right breast with
• The lateral view is taken, just like in stereotactic to provide a better three dimensional perspective. It gives just
that much more understanding of where the lesion is located making it worth the time and effort to acquire the
extra view.
• The lesion was seen subareolar at the 12 o’clock position on the breast (Figure 2, red arrow).
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• They then reviewed the CC projection from the diagnostic scan to decide if the approach will be medial or
lateral. Based on this image (Figure 2), the patient was able to be appropriately positioned.
Figure 3: Stereo Navigator 4 minute Initial Biopsy Scan of Right breast with half FOV
• On the Initial Biopsy Scan, the lesion was targeted with the breast in position.
• They could see the lateral compression and straightness of the breast compressed against the paddle (Figure 3,
red arrow) as well as the somewhat curved medial portion of the breast (Figure 3, blue arrow).
• Dr. Schilling prefers to target underneath the lesion, so she proceeded to the most inferior site where lesion is
visible, in this case, image #3 or #4 of 12 (Figure 3, yellow circle), and targeted under the lesion.
• The intent for targeting under the lesion is similar to targeting calcifications where one tries to avoid displacing
the calcifications once the targeting set is in place. Gravity can also be used to pull the appropriate tissue into
the aperture.
• The lesion was targeted on #3 or #4 and a Confirmation Scan was obtained. The initial image when the patient is
in position is usually obtained at 4 minutes to provide a higher resolution image. At this site they scan diagnostic
patients at 8 minutes but since they know where the lesion is, they don’t need higher resolution than 4 minutes
for biopsy.
• The Alignment Scan with the line source inserted is obtained for 2 minutes. A reduced imaging time is used so
as to not use up a lot of time taking additional images. The location of the line source as it’s approaching the
lesion can be seen on image #4 (Figure 4).
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source in slice 4 of 12 (red arrow)
Figure 4: 2 minute Alignment Scan showing line
• The line source can be seen pointed directly at the lesion (Figure 5). In this case it’s slightly in front of it so
biopsy approach was more towards the patient’s chest wall.
Figure 5: Alignment Scan showing line
source directed toward the lesion
• If it is decided that positioning needs to be adjusted or even during biopsy planning, it’s important to always
reference an anatomic part of the breast, for example, towards the nipple or towards the chest wall to limit
confusion.
• The next step is to place the biopsy probe and obtain specimens. When placing the cube in the grid, Dr. Schilling
puts the cube on the trocar first, then advances the tip of the trocar through the skin incision prior to loading it
onto the grid so that she knows that she has clear access through the skin incision before pushing into the final
depth.
• The user may also need to initially insert the needle deeper than software indicates, especially with dense breast
tissue as the lesion tends to push out. The user advances more than software indicates, and then pulls back.
For superficial lesions one may need to go in deeper than software indicates for proximal lesion location within
the aperture to avoid catching the skin.
• Typically since Dr. Schilling is targeting inferior to the lesion, she will biopsy from 10 to 2 o’clock if she is
appropriately positioned. In this case biopsying towards the chest wall at one hour intervals for approximately 4
hours total, going back and forth several times, if using an 8 gauge Mammotome probably at least 6 or 8 cores.
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• Post‐biopsy the lesion hasn’t changed that much (Figure 6). She had expected this to happen when they first
started doing biopsies, but generally they don’t see a change in the lesion morphology upon biopsy.
• It is apparent that more tissue has been removed so the lesion is more ill‐defined and of lower intensity (Figure
6, red arrow).
Figure 6: 4 minute Post-Biopsy Scan showing change in lesion morphology (red arrow)
• They then proceeded to the specimen image (Figure 7) and looked at the specimen itself. It is apparent that
uptake in the specimen is greater than background.
Figure 7: 1 minute Specimen Scan showing FDG uptake in the cores
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C. Sharing Best Practices from Other Sites
Dr. Dorfman – Zwanger‐Pesiri, Long Island, NY:
• Have done about 6 cases, all have gone smoothly. This site uses Suros and Dr. Dorfman prefers the 12 gauge but
only the 9 gauge is currently compatible with Stereo Navigator.
• Tends to target posterior or next to the lesion, based on his stereotactic point of view.
• Physician involvement has been 30‐45 minutes, the technologists time is more.
• Suggested that a poster be developed detailing the steps for PEM‐guided biopsy to remind the techs with
general steps they reference during a procedure.
• No difficult cases to report.
Dr. Argus – University of Cincinnati, Cincinnati, OH:
• One of Cincinnati’s earlier cases was for a lesion that didn’t seem posterior on the mammogram, and wasn’t on
the pectoralis muscle, but was on the posterior margin of the parenchyma. Had difficulty positioning to pull it
into the biopsy FOV. The case was successful, but it took a while. The Boca lateral approach may be helpful to
them.
• Cincinnati is still new at this they are still working on positioning.
• Also patient body habitus in their area makes it more challenging.
D. Discussion of How Lateral Medial view Helps Better Plan Biopsy
• In this example, can see that the lesion is in inferior lateral side on the CC (Figure 8, red arrow), but looking at
MLO (Figure 8, blue arrow), it suggests that it is above the nipple. Compression on the CC is not appropriate on
this example.
Figure 8: CC and MLO view of Right breast showing lesion on the inferior lateral side
• By comparing the Right MLO (Figure 9, blue arrow) with the Right Lateral (Figure 9 yellow arrow), can see that
the lesion is more in alignment with the nipple instead of above it. The LM view is useful because it provides a
better 3D view to help with biopsy planning.
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Figure 9: MLO and LM view of Right breast showing comparative lesion position
• Without proper positioning we will not appreciate whether the lesion is appropriately located. This is an issue
particularly when nuclear medicine technologists initially begin doing biopsies, and don’t apply sufficient
compression to the breast.
Figure 10: Individual MLO and LM view of Right breast showing comparative distance from nipple
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E. Other Comments on How to Improve the Product and the Procedure
• X, Y and Z Orientation:
o Dr. Schilling comments that X, Y, Z is different from Stereotactic and MRI. Z should be depth of the
needle – makes software confusing.
o Currently Z is the distance between the paddles. X is the needle depth.
o Per Dr. Dorfman, with an upright stereotactic unit, Z is also the distance between the paddles so it’s not
particularly confusing for him.
• Dual biopsies:
o Request by Drs Schilling and Argus to have two line sources available to be able to biopsy two lesions
during the same scan sequence to shorten imaging time. In MRI biopsy this can occur in 5‐10% of the
cases.
o Software will currently not permit you to target at one time (can do it sequentially).
o Also need to open two vacuum‐assisted biopsy kits.
o Work around is to use Post‐Biopsy Scan from first lesion to target your second. Labeling may be
confusing for technologists unless you obtained one Post‐Biopsy Scan for both.
• Biopsy Case Timing:
o Majority of the sites are performing biopsy on a separate day from the initial scan.
o Exceptions are related to insurance issues – when the insurer will only pay for one injection of 18FDG.
One patient without insurance had Dx PEM, WB PET and PEM‐guided biopsy all with one dose of 18FDG.
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