Clinical trial · Interventional
Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes
NCT02416336CI-TRIAL-00026800completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinella Intraoperative imaging protocol | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinella intraoperative use
- description
- 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
- interventionNames
- Device: Sentinella Intraoperative imaging protocol
Primary outcomes (1)
- measure
- The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.
- timeFrame
- 1 year
- description
- Primary endpoint The percentage of patients for whom Sentinella detects additional tumor-positive SLNs.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDStoffels 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
- BACKGROUNDVermeeren 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
- BACKGROUNDHellingman 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