Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes

NCT02416336 | Completed

• 1 other identifier: SLN-USA-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma; Head and Neck Cancer; Breast Cancer

Keywords

sentinel lymph node; lymphoscintigraphy; intraoperative gamma camera

Outcome Measures

Primary Outcomes (1)

• The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.

  Primary endpoint The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.

  1 year

Secondary Outcomes (3)

• Mean percentage of SLNs detected using pre-operative lymphoscintigraphy and/or SPECT/CT

  1 Year

• Additional SLNs per patient found using Sentinella

  1 Year

• Mean Sentinella imaging time

  1 Year

Study Arms (1)

Sentinella intraoperative use

EXPERIMENTAL

Standard of care intraoperative protocol 1. Localize SLN with the Gamma Probe for In vivo count 2. Optional (time permitting during surgical prep). Image same SLN with Sentinella (Pre-incision) 3. Surgically remove/excise localized SLN 4. Ex vivo count - excised SLN with Gamma Probe 5. In vivo background/roaming count with Gamma Probe 6. Repeat step 1-5, until no SLNs are found with the Gamma Probe (negative reading) Sentinella intraoperative imaging protocol 1. Survey surgical field/Post-excision control with Sentinella for remaining SLNs 2. If focal uptake seen in step 1, search for these occult SLNs with Gamma Probe and remove localized additional SLNs 3. Record information on data sheet for each excised SLN with Gamma Probe and Sentinella

Device: Sentinella Intraoperative imaging protocol

Interventions

Sentinella Intraoperative imaging protocol DEVICE

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 study will not increase the subject's overall procedure time. However, if the Sentinella camera detects something that the standard imaging techniques have missed, such as an additional sentinel node, the surgeon will do further exploration and tissue removal as needed.

Sentinella intraoperative use

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Oncovision Inc: lead
• California Pacific Medical Center: collaborator

Study Sites (1)

California Pacific Medical Center - Pacific Campus

San Francisco, California, 94115, United States

Location

Related Publications (3)

• 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 gamma-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 BACKGROUND

• Vermeeren L, Valdes 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Melanoma; Head and Neck Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)