Expired Study
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San Francisco, California 94115


Purpose:

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.


Study summary:

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 permanent record. 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 rates. 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 removal. - 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 patient's record. 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.


Criteria:

Inclusion Criteria: - 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.


Study is Available At:


Original ID:

SLN-USA-1


NCT ID:

NCT02416336


Secondary ID:


Study Acronym:


Brief Title:

Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes


Official Title:

Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Oncovision Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Actual


Study Dates

Start Date:July 2015
Completion Date:March 2017
Completion Type:Actual
Primary Completion Date:March 2017
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 3, 2017
First Received Date:April 7, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mean Sentinella imaging time
Time Frame:1 Year
Safety Issues:False
Description:Mean time required to complete intraoperative imaging with Sentinella. (After the surgery, the total image acquisition time for that patient can be found on Sentinella's database.)
Outcome Type:Secondary Outcome
Measure:Additional SLNs per patient found using Sentinella
Time Frame:1 Year
Safety Issues:False
Description:The proportion of patients who have additional SLNs found and the mean number of additional SLNs found per patient. This is to evaluate in how many patients additional SLNs are found with Sentinella after negative gamma probe screening. (Label these addit
Outcome Type:Secondary Outcome
Measure:Mean percentage of SLNs detected using pre-operative lymphoscintigraphy and/or SPECT/CT
Time Frame:1 Year
Safety Issues:False
Description:The mean percentage of excised SLNs among the total number of SLNs detected using preoperative lymphoscintigraphy and/or single-photon emission computed tomography (SPECT)/CT. This is to evaluate the percentage of intraoperatively found SLNs, which are pr
Outcome Type:Primary Outcome
Measure:The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.
Time Frame:1 year
Safety Issues:False
Description:Primary endpoint The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.

Study Interventions

Intervention Type:Device
Name:Sentinella Intraoperative imaging protocol
Description:There is a "holding" time of 15-20 minutes after the lymph node is removed during which the node is further dissected, examined and prepared for pathological analysis. This occurs before the procedure is completed in case the surgeon determines that further surgical exploration or tissue removal is required. In this study, the investigators will use this holding time to collect images of the sentinel lymph node area using the Sentinella camera for this study. Therefore, participation in this st
Arm Name:Sentinella intraoperative use

Study Arms

Study Arm Type:Experimental
Arm Name:Sentinella intraoperative use
Description:Standard of care intraoperative protocol Localize SLN with the Gamma Probe for In vivo count Optional (time permitting during surgical prep). Image same SLN with Sentinella (Pre-incision) Surgically remove/excise localized SLN Ex vivo count - excised SLN with Gamma Probe In vivo background/roaming count with Gamma Probe Repeat step 1-5, until no SLNs are found with the Gamma Probe (negative reading) Sentinella intraoperative imaging protocol Survey surgical field/Post-excision control wi

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Oncovision Inc
Agency Class:Other
Agency Type:Collaborator
Agency Name:California Pacific Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Stoffels I, Poeppel T, Boy C, Mueller S, Wichmann F, Dissemond J, Schadendorf D, Rosenbaum-Krumme S, Klode J. Radio-guided surgery: advantages of a new portable γ-camera (Sentinella) for intraoperative real time imaging and detection of sentinel lymph nodes in cutaneous malignancies. J Eur Acad Dermatol Venereol. 2012 Mar;26(3):308-13. doi: 10.1111/j.1468-3083.2011.04057.x. Epub 2011 Mar 23.
PMID:21429042
Reference Type:Reference
Citation:Vermeeren L, Valdés Olmos RA, Klop WM, Balm AJ, van den Brekel MW. A portable gamma-camera for intraoperative detection of sentinel nodes in the head and neck region. J Nucl Med. 2010 May;51(5):700-3. doi: 10.2967/jnumed.109.071407. Epub 2010 Apr 15.
PMID:20395319
Reference Type:Reference
Citation:Hellingman D, de Wit-van der Veen LJ, Klop WM, Olmos RA. Detecting near-the-injection-site sentinel nodes in head and neck melanomas with a high-resolution portable gamma camera. Clin Nucl Med. 2015 Jan;40(1):e11-6. doi: 10.1097/RLU.0000000000000370.
PMID:24662667

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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