Active clinical trials for "Melanoma"

The specific aim of this study is to determine if interactive touchscreen-based learning with deliberate practice modules can enhance the retention of life-saving medical skills when incorporated into medical training curricula. We will analyze the retention and confidence of screening skills by comparing outcomes on pretest and posttest in each arm.

The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.

Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination. The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.

The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which the investigators term the HRHV axis. Patients with in-transit melanoma (AJCC Stage IIIB or IIIC) (1) will be administered the hypoxia marker drug, EF5, 24 hr prior to isolated limb infusion (ILI) or hyperthermic isolated limb perfusion (HILP). Tumor biopsies will be performed just prior to ILI or HILP, at the 30 minute time point during ILI (or 60 minute time point during HILP), AND 24 hours after ILI or HILP. Tissues obtained will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will also be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in melanoma. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.

Melanoma incidence is increasing in most developed countries. At the metastatic stage, the prognosis is usually poor. Major advances have been obtained over the last 3 years with the development of therapies targeting the MAP kinases pathway. Vemurafenib (zelboraf®) is approved in France since 2012 as first treatment of metastatic melanoma carrying a B-RAF mutation. For growth, the tumor needs an adequate supply of nutrients to allow the synthesis of macromolecules and a contribution in carbon elements to ensure the production of energy. The nutrition demand is met through greater availability of nutrients via tumor angiogenesis and through increased intracellular penetration of nutrients via specific upregulation of transport systems and metabolic pathways. Scanner is the imaging method most commonly used for the evaluation of therapeutic response. Such a method gives a morphological indication but does not evaluate the metabolic response. With the development of functional imaging techniques and the advent of positron emission tomography (PET), it is now possible to obtain an assessment of the metabolic activity of tumors. The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly recent. The advantage of this approach is well documented for GIST and non-small cell lung cancer. In melanoma, the metabolic response to 18F-FDG is much faster than the response to TAP scanner. 18F-FDG tracer that targets glucose metabolism, is the most sensitive functional imaging in melanoma, which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT. The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease, a situation in which it can replace the TAP scanner, additional brain imaging remaining necessary. The use of metabolic imaging to study the response to targeted therapies in melanoma has been the subject of only one publications. There was a trend toward improved progression-free survival in patients with high metabolic response at day J15. For melanoma, the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG (64% versus 95%). In contrast, the 18F-FDOPA tracer has the advantage of allowing a brain assessment, which is critical in melanoma that gives frequent metastases in the central nervous system. There has never been any evaluation of the metabolic response to targeted therapies such as BRAF inhibitors PET with 18F-FDOPA. The investigators propose to conduct a monocentric prospective preliminary study to explore the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib.

The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. In comparing the patients will also get lymph-scintigraphy and sentinel node detection wiht blue dye. The goal is to improve the method for detecting sentinel node(s) in melanoma.

This is a feasibility study for the use of [18F]PD-L1 as a PET tracer that will be conducted in a single center. The study consists of two phases. The aim of phase one is to provide pharmacokinetic information on the tracer and to determine the optimal time point for imaging. In the second phase the main study objective will be assessed.

This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.

The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.