Breast Cancer Clinical Trial
Official title:
Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes
Verified date | April 2017 |
Source | Oncovision Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | California Pacific Medical Center - Pacific Campus | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Oncovision Inc | California Pacific Medical Center |
United States,
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. — View 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 ?-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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean percentage of SLNs detected using pre-operative lymphoscintigraphy and/or SPECT/CT | 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 preoperatively visualized by lymphoscintigraphy and/or SPECT/CT. | 1 Year | |
Secondary | Additional SLNs per patient found using Sentinella | 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 additional nodes as: post-excision control/same location, near-injection-site, deeply located/low-uptake SLNs, etc.). | 1 Year | |
Secondary | Mean Sentinella imaging time | 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.) | 1 Year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |