The aim of this study is to investigate whether the Sentinella camera improves
intraoperative detection and removal of sentinel lymph nodes (SLNs) when used in conjunction
with standard detection methods. Of primary interest is whether the Sentinella camera
identifies additional tumor-positive SLNs that are missed using traditional imaging
techniques. Other outcomes related to the standard of care use of the Sentinella camera may
also be assessed.
Sentinella is an FDA-approved, high-resolution, portable gamma camera that gives valuable
visual guidance to surgeons in certain types of cancer surgeries where no, or only limited,
visual guidance was possible previously. The significance of this new aid is the improved
possibility of locating and removing all lymph nodes that drain directly from
tumors—so-called "SLNs"—in order to accurately assess both the staging of the cancer as well
as the best possible operative and post-operative treatment. Sentinella can confirm that no
significant lymph nodes are missed and document this "clean field" on the patient's
Usually, there is more than one SLN. False-negative SLN biopsy results may impair patient
outcome for several reasons: missed nodes might lead to recurrence that can be potentially
difficult to treat on occasions, involved nodes may be a potential secondary source of
distant metastases, and understaging affects decisions about systemic therapy and specific
radiation therapy. Missing SLNs is one of the main factors which increase the false-negative
Sentinel node biopsy is undoubtedly the standard of care for breast cancer and melanoma
because of the vital information the histological status of these nodes gives. Correct
identification of these SLNs is challenging because of limitations of current preoperative
imaging and the lack of visualization in the OR:
- What appears to be a single node in a preoperative lymphoscintigraphy or SPECT can turn
out to be 2 or more different nodes that are close together. This is due to relatively
low spatial resolution of these technologies.
- Structures can be "hidden" by other structures such as the principle tumor/injection
site, making identification difficult or impossible. In these cases, Sentinella will
discover the structure upon removal of the principle tumor and aid the surgeon in its
- Currently used gamma probes give only audible and non-recorded aid to surgeons and can
easily miss structures when they are more than 2 cm deep in tissue.
Sentinella gives additional visual information to surgical teams that can improve patient
outcomes. It does not replace, but rather compliments current standard procedures, and it
offers precise documentation of each step of the procedure to be kept permanently on the
1. After standard injection of radiotracer and imaging are performed preoperatively,
Sentinella can be used in the OR to identify the position of the structures and mark
the skin for surgeon's reference.
2. Before removal, Sentinella can be used to visualize and quantify the radioactivity of
each structure. This information is stored for future reference.
3. Upon removal of each structure, Sentinella can be used to verify ex-vivo the activity
of the structure removed.
4. After removal and verification of all the structures planned, Sentinella is used to
confirm that no active structure is left in and to document the resulting "clean field"
The current standard of care for surgical SLN biopsy involves use of a gamma probe. In this
study, the investigators will prospectively collect Sentinella images obtained during this
standard of care procedure and compare and correlate the findings with other standard of
care imaging studies, and treatment and outcome information.
- All melanoma patients, with a Breslow thickness >1mm, who are seen at CPMC for
sentinel node biopsy will be eligible to participate in this study provided that they
have given consent.