Non-Surgical Sentinel Lymph Node Staging. Martin Horn1, Stefan Paepke2, Evelyn Klein2,. Thomas Wendler1,2 & Michael Friebe1 ,3. 1 SurgicEye GmbH ...
Hybrid Interventional Imaging For
Non-Surgical Sentinel Lymph Node Staging Martin Horn1, Stefan Paepke 2, Evelyn Klein 2,
Thomas Wendler 1,2 & Michael Friebe 1 ,3 SurgicEye GmbH, München, Germany 2 TU München & Klinikum rechts der Isar, München, Germany 3 OvGU University, Magdeburg, Germany 1
Motivation for non-surgical sentinel lymph node biopsy Motivation: Moving the sentinel lymph node biopsy from an invasive to a non-surgical procedure. Indication: In patients with early breast cancer and clinically negative lymph nodes (40k cases p.a. in Germany), also already initially evaluated for melanoma, head and neck Proposed Benefits: – Less complications – Sparing surgeries – Less radiation – Reducing OR costs – Enabling ambulatory care
Workflow of sentinel lymph node biopsy from a surgical to non-surgical procedure
Low dose radioactive labelling
.
Localization with gamma probe
Surgical removal of SLN(s)
Histological examination
invasive axilla surgery as part of primary breast surgery or
stand alone axilla surgery
Workflow of sentinel lymph node biopsy from a surgical to non-surgical procedure
Low dose radioactive labelling
SLN imaging with SPECT/US fusion
US-guided biopsy of identified SLN
replaced by non-surgical biopsy procedure .
Histological examination
What is the technology to enable non-surgical sentinal lymph node biospy Combining imaging & biopsy of the SLN in an all-in-one solution Imaging
Biopsy
Precise SLN identification using fusion of real-time ultrasound and mobile SPECT
Needle biopsy under ultrasound fusion guidance to reduce the sampling error
Ultrasound
Single insertion
needle biopsy
Handheld gamma camera
Step 1: SPECT acquisition Step 2: Ultrasound Fusion Defining a joint coordinate frame c) Fus
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Step 3: Ultrasound guided biopsy
Example procedure of a non-surgical sentinel lymph node biopsy
http://youtu.be/h7pKLfYw2wA
Validation of the handheld SPECT imaging Comparison of scintigraphy with freehand SPECT imaging Example examination
Scintigraphy
freehandSPECT(3 planes)
NM
OR
SLNs in scintigraphy
53
18
SLNs in fhSPECT IP
53
18
secondary LNs in scintigraphy
27
3
secondary LNs in fhSPECT IP
24
2
additional secondary LNs in fhSPECT IP
5
2
AR view of freehandSPECT
Pfob, Paepke, Martignoni, Horn, Wendler, Scheidhauer, and Schwaiger, “Comparison of 3D SPECT using handheld gamma camera with planar scintigraphy in example sentinel lymph node mapping,” in SNM-MI, Baltimore, MA, USA, 2015.
Scintigrapy shows SLN
Freehand SPECT shows identical SLN
Ultrasound guided biopsy
Case Example 1
Ultrasound overlay guide needle to SLN
Case Example 2
Patient
69, female
Tumor status
invasive lobular MammaCa G2 pT3
SLN size
12,9 x 10,6mm
SLN depth
23mm
Biopsy technique
VAB 13G
Case Example 2 SPECT/US image of SLN
Ultrasound image of SLN
Ultrasound image of SLN with realtime SPECT-Overlay
Case Example 2
No. of samples
2
Radioactivity in sample?
Yes
Lymph node tissue in sample?
Yes
Dignity of SLN sample?
pN1
Surgical removal of remaining SLN tissue?
Yes
Dignity of surgical removed residual SLN?
pN1
Total duration of procedure
(including patient preparation and imaging)
20 min
Result: true positive
Summary of the first 38 patients
to be presented at DGS June 28, 2015 in Leipzig
Lessons learned A non surgical sentinel lymph node biopsy is feasible and has no side effects Changing a clinical procedure has a long learning curve to adopt Usability if very critical for the performance Larger study is required to confirm that the diagnostic value of a needle biopsy is equivalent to the surgical removal The technical parameter influence the performance • Resolution & contrast of the ultrasound for identification of the lymph node and precise guidance of the needle • Resolution of the SPECT imaging to identify the sentinel lymph node • Accuracy of the overlay to map and biopsy the right lymph node • Needle technology – compromise between large (more sample tissue / more damage) and small (less sample tissue / less damage) needles
Future Work - Technical Increase usability by one tracking solution
Future Work – Clinical Validation Study concept towards making non surgical SLNB clinical standard
References / Literature on non-surgical SLNB & hybrid SPECT/US imaging
❑ M. Friebe, J. Traub, T. Wendler, S. Wiesner, S. Paepke, M. Keicher, and M. Horn, “Hybrid interventional imaging for non-surgical SLNB Staging,” in SMIT Proceedings, 2014. ❑ M. Freesmeyer, T. Winkens, T. Opfermann, P. Elsner, I. Runnebaum, and A. Darr, “Real-time ultrasound and freehand-SPECT: Experiences with sentinel lymph node mapping,” Nuklearmedizin, vol. 53, no. 6, Jul. 2014. ❑ Okur et al; fhSPECT-US Guided Punch Biopsy of Sentinel Lymph Nodes in the Axilla: Is it Feasible?; MICCAI 2014 ❑ M. Freesmeyer, T. Opfermann, and T. Winkens, “Hybrid Integration of Real-time US and Freehand SPECT: Proof of Concept in Patients with Thyroid Diseases,” Radiology, vol. 271, no. 3, pp. 856–861, Jan. 2014. ❑ S. Paepke, C. Pfob, R. Ohlinger, M. Thill, T. Kühn, J.-U. Blohmer, M. Hahn, I. Gruber, K. Scheidhauer, and M. Kiechle, “From radical to minimal-invasive – first clinical results of a nonsurgical SLNB,” in 15. St. Gallen Breast Cancer Conference, Vienna, Austria, 2015. ❑ Pfob, Paepke, Martignoni, Horn, Wendler, Scheidhauer, and Schwaiger, “Comparison of 3D SPECT using handheld gamma camera with planar scintigraphy in example sentinel lymph node mapping,” in SNM-MI, Baltimore, MA, USA, 2015. ❑ Paepke, S., Ohlinger, R., Blohmer, J.-U., Thill, M., Gruber, I., Hahn, M., Kuehn, T. and Work Group on Minimally-Invasive Breast Interventions of the German Society of Senology, Survery on axillary lymph node biopsy in Germany, Annual Meeting of the German Society of Senology, Leipzig, June 2015
Thanks a lot for your attention
& credits to all co-authors and collaborators!
Martin Horn1, Stefan Paepke 2, Evelyn Klein 2,
Thomas Wendler 1,2 & Michael Friebe 1 ,3 SurgicEye GmbH, München, Germany 2 TU München & Klinikum rechts der Isar, München, Germany 3 OvGU University, Magdeburg, Germany 1