Hybrid Interventional Imaging For Non-Surgical Sentinel Lymph Node ...

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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

ion of

SPEC

T in U

a)

ltrasou

nd

CT

E SP re en

r fe ce (o ica pt l)

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b)U

S

e ref

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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