sentinel node: practical experience at frimley park hospital rj morton, a fullbrook, l wright, jrw...

Sentinel Node:Practical Experience at Frimley Park

Hospital

RJ Morton, A Fullbrook, L Wright, JRW Hall, J Ward

History

• 1951 Parotid (Gould)• 1977 Penile (Cabanas)• 1966 Testicular• 1992 Melanoma

• 1970 Breast (Blue Dye)• 1990’s Breast (Radionuclide)

What is Sentinel Lymph Node (SLN)?

• The Sentinel Node is any node which receives drainage directly from the primary tumour

SLN SLN SLN

Secondary nodeSLN

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

SLN:The first node to receive lymph drainage directly from tumour

Other nodes will be clearSN-

Tumour

SN+ Other nodes may contain cancer

the node that predicts lymph node status

Diagnosis: who is eligible?

Eligibility: Virtually any cancer patient who requires lymph node staging.

Exclusions: Gross nodal disease and/or signs oflymphatic obstruction. Distant metastases

NEW STARTSLN 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

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)

NEW STARTSLN training programme: Overview

Theory Day

In House Training

Mentoring&

Validation

12-18 months

Stand alone

SLNBSkills SLNB + standard procedureTheory

Ongoing Audit

5 cases per surgeon 25 cases per surgeon

Theory

FPH - SLN

• Started 1999 (breast and melanoma)– Research ARSAC

• Full ARSAC (Dec 2003)

• 229 (1999-April 2005)

Patient Journey

Diagnosis Nuclear Medicine Surgery Pathology

99Tcm Nanocolloid Blue Dye

SLN

10 mins

Imaging

2 – 3 hours

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

Injection Technique

Periareolar/Sub dermal(<5% negative node)

Peritumour

Ultrasonic control (15% negative node)

SLN Injection Technique – Suggested Protocol for NEW START

  Palpable Impalpable

No prior excision biopsy

15–40 MBq in 0.2ml 99mTc-Nanocoll

injected intradermally overlying tumour

15–40 MBq in 0.2ml 99mTc-Nanocoll

periareolar intradermal injection in index quadrant

Prior excision biopsy

2 x 10-25 MBq in 0.2ml 99mTc-Nanocoll

injected intradermally

either side of excision scar

2 x 10-25 MBq in 0.2ml 99mTc-Nanocoll

injected intradermally

either side of excision scar

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)

Injection technique continued

• Massage injection site• Tape gauze over injection site• Disease side only

Melanoma– 4 injections around the scar

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

Mark Nodes

• Mark nodes using Co-57 pen source

• Oblique view (Ant for internal)

• Indelible pen

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

Single Node

Multiple Nodes

Negative Image

• <5 % -Negative node rate

Importance of Oblique Image

Internal Mammary

Unexpected Results

Surgery

1.Blue dye injection 2mls in 4-5 mls saline

(allergic reaction 1.8%, hypotension 0.2%)

2. Identify SLN : Colour and Counts

Gamma Probes

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

77

82

96

3.4

0 10 20 30 40 50 60 70 80 90 100

Blue node

Hot node

Hot or bluenode

Failedlocalisation

SLN identification

ALMANAC TRIAL AUDIT PHASE

% Success in finding sentinel node

Results from FPH

• 96 consecutive cases• Located nodes 96.5 % (Standard >95%)• Failed localisation 1%• 2.6 nodes average• 28.4 % node positive (Standard 20-

30%)

SLNB:Safety

• Extensive clinical experience/follow up in USA/Europe (individual series of 2-3000 cases)

• Early data demonstrates very low local recurrence rates

Legislation

• Environment Agency

• ARSAC – Nuclear Medicine Specialist– Surgeon undertaking SLN biopsy as an operator– Provide proof that surgeon is undergoing

training (NEW START)

Radiation Protection

• Patient: 20MBq ED 0.42 mSv• Surgeon:

– Whole body dose 1.9 Sv/case

– Finger dose 13 Sv/case500 cases before annual limit is reached

Morton et al: BJR 2003, (76) 117-122

Local Radiation Protection Department

Theatre

– May need to store for 48 hours

• Contamination– Normal precautions for biohazards

• Training/Instruction sheet for staff

Same day 0.2 - 1.9 MBq

Next day 0.001 - 0.1 MBq

• Waste

Pathology

• Pathologist

• Fix immediately but leave for 24 hours before section

• Label samples as radioactive and store away from the main area

UK Probe Working Group

To produce guidance on issues relating to the Gamma Probe in SNB

– Purchase

– Evaluation

– Quality Assurance

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)

Probe QC