Alessandro Testori

Director melanoma & sarcoma division

IEO Milan

Sentinel node biopsy technologies

Disclosure Received financial travel supports from companies involved in this presentation

Alessandro Testori, MD Director Melanoma and Muscle Cutaneous Sarcoma Division IEO- European Institute of Oncology

IMPROVEMENT OF SENTINEL NODE IDENTIFICATION BY

VALIDATION OF THE USE OF THE SENTINELLA EQUIPMENT

vs THE USE OF ONLY GAMMAPROBE

A PILOT STUDY

Traditional Gamma Probe

(+/- Blue dye)

SNB accuracy: False neg rate = false neg/false neg + true positive = 15-20%

Nodal recurrence after neg SNB

4 possible explanations

1.Tumoral cells still migrating from primary to the basin??? 2.Lymphoscintigraphy by-pass of positive node/s (pre op US may help in case of not palpable pathological node/s) 3.Surgical unsuccess 4.Pathological mis-diagnosis

Evaluation of the efficacy to detect the sentinel node using the

traditional Gamma probe VS

using the Gamma probe and the intraoperative gamma camera by Sentinella equipment:

A Pilot Study

Aim of the study

SENTINELLA: New eyes in operating theater

Integral equipment camera + probe+ pointer+ software

• Written informed consent for the surgical and experimental instrumental procedure

• Between 18 and 75 years of age

• Histologically confirmed Primary cutaneous tumour

• ECOG Performance Status 0-1

• Life expectancy of at least 10 years from the time of diagnosis, (not considering skin npl)

• Willing to return to the hospital for follow up examinations and procedure

Inclusion Criteria

The proposed protocol

Step 1. Preoperative and/or early intraoperative assessment of lymph nodes Sentinella gammacamera positioned at 5 to 10 cm distance to lymph node area Anteroposterior and lateral views, depending on lymph nodes location 30 seconds to 2 minutes Step 2. Intraoperative pinpointing and guided resection of lymph nodes Standard gamma probe used to perform sentinel nodes biopsy

Step 3. Confirmation of successful resection / clean field Sentinella gammacamera positioned at 5 to 10 cm distance to lymph node area. Anteroposterior and lateral views, depending on lymph node location 30 seconds to 2 minutes Excision of further nodes if the gamma camera has documented any residual node not identified with the standard gamma probe approach

• Primary melanoma of the eye, ears, internal viscera • Physical, clinical, radiographic evidence distant metastatic disease • Any additional solid tumor or hematologic malignancy during the past 5

years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical cancer

• Skin grafts, tissue transfers or flap that have the potential to alter the lymphatic drainage pattern from the primary melanoma to LN basin

• Allergy to any radio-colloid • Organic brain syndrome or significant impairment of basal cognitive

function or any psychiatric disorder that might preclude participation in the full protocol, or be exacerbated by therapy

• Melanoma related operative procedures not corresponding to criteria described in the protocol

• Primary or secondary immune deficiencies or know significant autoimmune disease

• History of organ transplantation • Oral or parenteral immuno-suppressive agents at any time during study

participation or within 6 months prior to enrollment • Pregnant or lactating women • Participation in concurrent experimental protocols or alternative

therapies that might confound the analysis of this trial

Exclusion Criteria

SENTINELLA: New eyes in operating theater

Surgical field after excision

Accrual: 289 patients will be enrolled in the study. Statistical evaluation has been proposed on the basis of forecasted: 1) increase of positive SNs removed

with Sentinella 102 gamma camera

Accrual: The statistical hypothesis is to find a 7% of further positive sentinel nodes with the Sentinella 102 gamma-camera at the end of the procedure with the gamma-probe surgical procedure. A sample size of 289 achieves 80% power to detect a difference in proportion of positive SN of 7% (from 20% to 27%) using a two-sided binomial test. The actual significance level achieved by this test is 5%. These results assume that the population proportion of positive SN under the null hypothesis is 20%

Thank-you

alessandro.testori@ieo.it