SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer

From the subject's viewpoint, the course of events in this study will be no different than
usual care and sentinel node biopsy. Subjects will have a dermal injection of technetium99
(tech99) at the melanoma tumor site prior to surgery (either the day before, or morning of
surgery) or a subareolar injection if breast cancer. The surgeon will not look at the
lymphoscintigraphy films, and the radiologist should not mark the skin. When the subject is
in the operating room and appropriately sedated or anesthetized, tthey will receive a dermal
injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if
breast cancer. Incision is made in the axilla or groin, and the SPY machine is positioned
over the lymph node basin. Real-time lymphangiography (SPY) is used to identify sentinel
nodes. Any fluorescent nodes should be resected and are considered sentinel nodes. The
absolute fluorescence will be quantified for each sentinel node. Absolute fluorescence is
calculated by the SPY machine.

After the sentinel lymphadenectomy is complete but prior to closing skin, the excised lymph
nodes will be examined with the gamma probe (detects tech99 signal) to confirm that they are
sentinel nodes. If the node does not have a signal with the gamma probe (but is fluorescent)
it is still considered a sentinel node. The lymph node basin will also be examined with the
gamma probe, to insure that no sentinel nodes are missed. If a gamma positive sentinel node
is identified in the lymph node basin, it should be resected and imaged with SPY. If no
sentinel nodes are able to be identified with fluorescent imaging, the gamma probe will be
used as per usual practice. The surgeon should spend no more than 30 minutes using SPY to
identify sentinel nodes. If after 30 minutes no sentinel node is found, the gamma probe
should be used. The data collection form should be completed for each case.

The investigators intend to enroll at least 48 subjects. In order to insure that the data
collected accurately represents the effectiveness of the SPY machine, each surgeon will be
required to enroll at least 8 subjects into the study. Sentinel node biopsy is a routine
surgical procedure, and all involved PIs are experienced in performing sentinel node biopsy.
While fluorescence imaging intra-op is novel, the actual procedure itself is no different.

Inclusion Criteria:

- Patients with melanoma or breast cancer who meet criteria for and consent to sentinel
node biopsy.The melanoma should be located on the upper extremity between and
including the wrist and shoulder, or the lower extremity between and including the
ankle and groin.

Exclusion Criteria:

- Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine
green or sodium iodide. Pregnant and nursing women. Patients who have had a prior
sentinel node biopsy in the same nodal basin.