1. Sentinel Node: Practical Experience at Frimley Park Hospital RJ Morton, A Fullbrook, L Wright, JRW Hall, J Ward

2. History 1951Parotid (Gould) 1977Penile (Cabanas) 1966Testicular 1992Melanoma 1970Breast (Blue Dye) 1990’sBreast (Radionuclide)

4. What is Sentinel Lymph Node (SLN)? The Sentinel Node is any node which receives drainage directly from the primary tumour SLN Secondary node SLN

5. Why SLN? Morbidity of traditional axillary surgery (e.g. lymphoedema, seroma, numbness, stiff shoulder) Diagnosing more early node negative breast cancer Development of a minimally invasive, safe, reproducible and accurate technique to predict nodal status

6. SLN:The first node to receive lymph drainage directly from tumour Other nodes will be clear SN- Tumour SN+ Other nodes may contain cancer the node that predicts lymph node status

7. Diagnosis: who is eligible? Eligibility: Virtually any cancer patient who requires lymph node staging. Exclusions: Gross nodal disease and/or signs of lymphatic obstruction. Distant metastases

8. NEW START SLN training programme 2004-2006 Joint Project Department of Education: Royal College of Surgeons of England Cardiff University Wales Supported by DoH, National Assembly in Wales GE Healthcare

9. What is New Start? National Training Programme Standardised methodology and training materials Focus on multidiscipline team – Surgery, Nuclear medicine/physics, Radiology, BCN, Theatre nurses, Pathology, etc Experienced validated training teams Unique workplace training and mentorship Quality assured Centrally audited and validated (anonymised data collection)

10. NEW START SLN training programme: Overview Theory Day In House Training Mentoring & Validation 12-18 months Stand alone SLNB SkillsSLNB + standard procedure Theory Ongoing Audit 5 cases per surgeon25 cases per surgeon Theory

11. FPH - SLN Started 1999 (breast and melanoma) –Research ARSAC Full ARSAC (Dec 2003) 229 (1999-April 2005)

12. Patient Journey DiagnosisNuclear MedicineSurgeryPathology 99 Tc m NanocolloidBlue Dye SLN 10 mins Imaging 2 – 3 hours

13. Request Form Next Day –Good image statistics –Lower radiation dose/protection issues –Surgeon finds node easier to locate (less shine through from injection site) Same Day –Convenient

14. Injection Technique Periareolar/Sub dermal (<5% negative node) Peritumour Ultrasonic control (15% negative node)

15. SLN Injection Technique – Suggested Protocol for NEW START PalpableImpalpable No prior excision biopsy 15–40 MBq in 0.2ml 99m Tc-Nanocoll injected intradermally overlying tumour 15–40 MBq in 0.2ml 99m Tc-Nanocoll periareolar intradermal injection in index quadrant Prior excision biopsy 2 x 10-25 MBq in 0.2ml 99m Tc-Nanocoll injected intradermally either side of excision scar 2 x 10-25 MBq in 0.2ml 99m Tc-Nanocoll injected intradermally either side of excision scar

16. Injection Technique (Breast) at FPH Cloth/inco pad around injection site Site – periareolar Tc-99m Nanocolloid 4 injections (0.5 ml each) –1 ml in each syringe –25 gauge needle Activity –20 MBq (same day) –40 MBq (next day)

17. Injection technique continued Massage injection site Tape gauze over injection site Disease side only Melanoma –4 injections around the scar

18. Imaging - Breast 2 – 3 hours post injection Supine Arms raised LEHR 256 matrix 300s static Full field (pixel size: 2.35mm) Ant, lateral, oblique Cobalt source –body outline

20. Mark Nodes Mark nodes using Co- 57 pen source Oblique view (Ant for internal) Indelible pen

21. Imaging - Melanoma Dynamic –45 * 20s frames –128 matrix –LEHR –Area above injection site Static –2 – 3 hours –256 matrix –LEHR –300 s –Ant, Lateral, oblique –Axilla/groin

22. Single Node

23. Multiple Nodes

24. Negative Image <5 % -Negative node rate

25. Importance of Oblique Image

26. Internal Mammary

27. Unexpected Results

28. Surgery 1.Blue dye injection 2mls in 4-5 mls saline (allergic reaction 1.8%, hypotension 0.2%) 2. Identify SLN : Colour and Counts

29. Gamma Probes

30. Surgery Frozen Section –Takes up to 45 mins –Immediate axillary dissection SLN biopsy – second operation for reconstruction and axillary clearance if necessary Reconstruction with SLN –Only return to theatre if SLN positive. –Greater risk of damage to reconstruction

31. ALMANAC TRIAL AUDIT PHASE % Success in finding sentinel node

32. Results from FPH 96 consecutive cases Located nodes 96.5% (Standard >95%) Failed localisation1% 2.6 nodes average 28.4 % node positive (Standard 20-30%)

33. SLNB:Safety Extensive clinical experience/follow up in USA/Europe (individual series of 2-3000 cases) Early data demonstrates very low local recurrence rates

34. Legislation Environment Agency ARSAC –Nuclear Medicine Specialist –Surgeon undertaking SLN biopsy as an operator –Provide proof that surgeon is undergoing training (NEW START)

35. Radiation Protection Patient: 20MBqED 0.42 mSv Surgeon: –Whole body dose1.9  Sv/case –Finger dose13  Sv/case 500 cases before annual limit is reached Morton et al: BJR 2003, (76) 117-122 Local Radiation Protection Department

36. Theatre –May need to store for 48 hours Contamination –Normal precautions for biohazards Training/Instruction sheet for staff Waste

37. Pathology Pathologist Fix immediately but leave for 24 hours before section Label samples as radioactive and store away from the main area

38. UK Probe Working Group To produce guidance on issues relating to the Gamma Probe in SNB –Purchase –Evaluation –Quality Assurance

39. Output BNMS web site (October 2004) –Gamma Probe Purchase Specification –Guide to User Evaluation In draft –Quality Assurance guidelines –Performance Evaluation –(Guidelines on use for surgeons)

40. Probe QC