Topic: Intraoperative Imaging in Melanoma Surgery Speaker: Alessandro Testori

1. Alessandro Testori
Director melanoma & sarcoma division
IEO Milan
Sentinel node biopsy
technologies
Disclosure
Received financial travel supports
from companies involved in this presentation

2. 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

3. Traditional Gamma Probe
(+/- Blue dye)
SNB accuracy:
False neg rate = false neg/false neg + true positive = 15-20%

4. 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

5. 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

6. SENTINELLA: New eyes in operating theater
Integral equipment
camera + probe+
pointer+ software

7. • 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

8. 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

9. • 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

10. SENTINELLA: New eyes in operating theater

11. Surgical field after excision

12. 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

13. 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%

14. Thank-you
alessandro.testori@ieo.it