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Showing 1-10 of 10 trials
NCT07552597
A randomized, international, phase III, multi-center, non- inferiority trial assessing the safety and efficacy of Magtrace® (superparamagnetic iron oxide, SPIO) in identification of lymph nodes in patients with cutaneous melanoma undergoing a sentinel lymph node biopsy (SLNB). Participants will be injected with both tracer methods Technetium (Tc99) plus Blue Dye (BD) and Magtrace®). They will undergo both a lymphoscintigraphy and a Magnetic Resonance Imaging (MRI) of the SLN basins. Before surgery, the participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99/BD and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99/BD. Randomization will be stratified by study site using permuted variable block sizes.
NCT07287917
This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups: * Cohort 1: Patients with ER+ / HER2- breast cancer receiving fulvestrant and capivasertib * Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab The Phase 1b portion will find the recommended Phase 2 dose (RP2D). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1). The study will also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.
NCT07429123
The goal of this observational study is to learn if an artificial intelligence (AI) tool helps primary care practitioners better identify skin conditions. The study focuses on adults with suspected skin pathologies, including tumor, inflammatory, and infectious diseases. The main questions it aims to answer are: * Does using the AI tool help doctors make more accurate diagnoses for multiple skin conditions? * Does the tool help doctors better decide which patients need a referral to a dermatologist and which can be managed in primary care? * Are doctors satisfied with how well the tool works and how easy it is to use in their daily work? * Can the tool help doctors more accurately differentiate between benign lesions and skin cancer? Participants will: * Visit their primary care doctor for a regular skin checkup. * Have photos taken of their skin condition using a smartphone or a dermatoscope. * Provide informed consent for their photos and basic health information (such as age and sex) to be analyzed by the AI tool. * Receive standard care from their doctor, with the tool providing a second opinion to assist in the clinical decision-making process.
NCT07428941
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions. Skin issues are a frequent reason for doctor visits, but differences in expertise between general practitioners and specialists can sometimes lead to misdiagnoses or unnecessary referrals. The researchers hypothesized that the information provided by the AI device would increase the true diagnostic accuracy of primary care practitioners for multiple dermatological conditions. To test this, the study followed a prospective, self-controlled design where each participating doctor served as their own comparison. During the study, 9 primary care physicians evaluated 30 clinical images representing a variety of skin pathologies. For each image, the doctors followed a two-step process: * First, they provided a diagnosis based only on the image and the patient's medical history. * Second, they were shown the AI's analysis-including the top 5 suggested diagnoses and confidence levels-and asked to provide a final diagnosis. The study also investigated if the AI could help doctors decide whether a patient truly needs a referral to a specialist or if the condition could be handled remotely via teledermatology. The primary question was whether using this AI support would significantly increase the number of correct diagnoses made by primary care doctors and lead to more efficient patient care.
NCT07410676
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced/metastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.
NCT07341737
Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.
NCT06545682
To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.
NCT06605443
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.
NCT06788665
In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis. Melanomas that only grow in the epidermis and have not yet grown into the dermis are called melanoma in situ or pre-melanoma. These melanomas lack the potential to spread in the body. Melanomas that grow into the dermis, on the other hand, are called invasive or malignant melanomas. Invasive melanomas have the potential to spread in the body. To improve melanoma diagnostics, a dermatoscope is used. A dermatoscope is a type of magnifying glass equipped with a strong light. Using a dermatoscope makes the structures in the epidermis and dermis clearer. Although most melanomas are relatively easy to detect, it is often difficult to determine whether melanomas are invasive or in situ based on the dermatoscopic image. Despite the fact that all suspected melanomas (regardless of melanoma depth) should be operated on, it is important to form an opinion on whether the melanoma is invasive or in situ. This decision is important because it: 1. Provides guidance on how quickly healthcare must prioritize a patient for surgery. 2. Provides guidance on the margin the surgeon chooses for the first operation. 3. Affects the information we give the patient even before the first operation. In recent years, several applications of machine learning have shown great potential in research contexts within dermatology and venereology. However, these tools have been evaluated to a very limited extent in clinical trials, which is naturally a prerequisite before they can be safely implemented in routine healthcare.
NCT03057327
The proposed study is a pilot and feasibility study designed to develop materials to enhance early detection of melanomas among women at risk to develop melanoma due to indoor tanning, having a family history of melanoma or a personal history of melanoma. The hypothesis of this study is that women, who are engaged in health promotion by having mammograms, will be able to assess the personal relevance of skin self-examination (SSE), be interested in learning about SSE and able to implement SSE while they are partially disrobed in the privacy of the changing room in the mammogram facility.