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A negative pressure wound dressing is placed over the skin graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.

A conventional antimicrobial wound dressing is placed on top of the graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.

Negative-pressure therapy postoperatively on the full-thickness skin graft

Negative pressure device

Conventional dressing postoperatively on the full-thickness skin graft

Conventional care

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications

Helsinki University Central Hospital

Principal investigator

Rare Diseases

Soft Tissue Neoplasms

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. Tumor response to DaRT will be assessed periodically 3 months after removal.

Diffusing Alpha-emitter Radiation Therapy (DaRT) is a method of delivering interstitial brachytherapy, based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life). These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. As the radioisotope has a short half-life, the majority of radiation absorption happens in the tumor.

Diffusing Alpha-emitter Radiation Therapy

Christopher Barker, MD

This is a single-institution pilot feasibility trial in which 10 subjects will be enrolled. The primary objectives are is to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using DaRT (Alpha Tau Medical, Tel Aviv, Israel), a form of interstitial brachytherapy which uses a novel radioisotope delivery system, as well as to determine the frequency and severity of acute adverse events. Secondary objectives will include assessments of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and associations with quality of life.

Diffusing Alpha-emitter Radiation Therapy is a form of interstitial brachytherapy which may be effective in treating malignant skin and superficial soft tissue tumors for several reasons. First, alpha-emitting radionuclides have a high linear energy transfer (LET), which produces a dense track of ionization events within cells and DNA, which produce complex DNA damage and more effective cell kill than more sparsely ionizing forms of radiation, such as gamma-rays or x-rays. Second, alpha-emitting radionuclides exhibit a higher relative biologic effect (RBE) compared to gamma-rays or x-rays, due to the relative insensitivity to cancer cellular radiosensitivity associated with cell cycling. Finally, alpha-emitting radionuclides are relatively insensitive to hypoxia, which is common as malignant skin and superficial soft tissue tumors become larger (Hall 2000).

Alpha particles have been considered unsuitable for treatment of solid tumors, since no practical method to effectively irradiate a macroscopic tumor with these short-range particles (penetration range in human tissue of ≤0.1 mm) has been found.

The "Diffusing Alpha-emitter Radiation Therapy (DaRT)", based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life), is described in this study. These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. These atoms are dispersed in the immediate surrounding tumor microenvironment both by convection through tumor interstitial fluid and by thermal diffusion. The decay of Radium-224 in the capsule results in the release of the short-lived (half-life of about 1 minute) radioisotope Radon-220. Radon-220 migrates in the tumor microenvironment until it decays. This is followed by the decay of its daughter radioisotope, Polonium-216. Lead-212, the result of this last decay, gives rise to Bismuth-212, which emits yet another alpha particle. The result of these decay events is the release of alpha particles (Kelson 1994 and Kelson 1995). DaRT will be used in this study for the treatment of malignant skin and superficial soft tissue tumors.

This study has been designed to determine the feasibility of performing the procedure required to deliver radiotherapy to the tumor. At the same time, the safety of the treatment, tumor response, radiation safety, device placement stability, and patient reported quality of life, and molecular and histologic effects on the tumor will be assessed.

The DaRT sources will be inserted using preplanned radiotherapy parameters, with a specified number and size of DaRT sources. Approximately 2-3 weeks after placement of the DaRT sources, the placement of the sources will be reassessed by volumetric imaging, and then they will be removed. Tumor response to DaRT will be assessed periodically 3 months after removal of the device.

This is a single-institution pilot feasibility trial in which 10 subjects will be enrolled.

The primary objectives are is to explore the feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using DaRT (Alpha Tau Medical, Tel Aviv, Israel), a form of interstitial brachytherapy which uses a novel radioisotope delivery system, as well as to determine the frequency and severity of acute adverse events. Secondary objectives will include assessments of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and associations with quality of life.

This is a multi-center feasibility trial with DaRT for the treatment of malignant skin and superficial soft tissue tumors.

Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors

A Pilot Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin and Superficial Soft Tissue Tumors

To explore feasibility of delivering radiotherapy for malignant skin and superficial soft tissue tumors using Diffusing Alpha-emitter Radiation Therapy (DaRT). Feasibility will be determined by successful delivery of radiation by DaRT to the malignant tumor. If an attempt to place the DaRT is unsuccessful, this patient will be considered a feasibility failure. A feasibility failure may be due to inability to execute the workflow of pre-brachytherapy imaging, treatment planning, device procurement, or technical inability to place the DaRT sources into the skin and superficial soft tissue tumor. The rate of feasibility failures will be reported.

To determine the frequency and severity of acute adverse events related to DaRT for skin and superficial soft tissue tumors. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

To assess the rate of malignant skin and superficial soft tissue tumor response after DaRT. Tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using calibrated digital photography and CT imaging 3 months after DaRT.

To assess radiation safety through determination of patient and personnel radiation exposure during DaRT. Radiation exposure will be measured using a calibrated survey probe.

To assess stability of the DaRT sources after placement. Stability will be assessed by localization of the DaRT sources in the tumor after placement, measured by geometric comparisons of the DaRT sources relative to the centroid of the tumor, using brachytherapy planning software. Distance of the DaRT sources relative to the centroid immediately at the time of initial placement and immediately before removal will be analyzed and reported numerically.

To assess skin-related and cancer-related quality of life (QoL) after DaRT. QoL will be assessed using the Skindex-16 following placement of the DaRT. The Skindex-16 scores range from 0 to 100 (with higher scores representing lower satisfaction).

To assess skin-related and cancer-related quality of life (QoL) after DaRT. QoL will be assessed using the Skin Cancer Index (SCI) following placement of the DaRT. The SCI scores range from 5-22 (with higher scores indicating higher QOL).

Alpha Tau Medical LTD.

A Real-time Augmented Reality Device with Artificial Intelligence Integration, acquisition of patient skin lesion images as data

Patients are diagnosed and treated with the assistance of artificial intelligence, augmented reality and new optical imaging technology, which is different from traditional model.

A Real-time Augmented Reality Device with Artificial Intelligence Integration

Kai Huang

In response to clinical needs, infrared multi-spectral images are combined with traditional clinical images and other multi-modal data to build a more efficient intelligent auxiliary diagnosis system and intelligent equipment for skin health and diseases, including skin lesions automatically segmentation on skin diseases images, automatically design surgical margin and planning for skin tumor surgery.

Database: Relying on the preliminary foundation, build the first standardized infrared multispectral image database of skin diseases, and further integrate other medical images and medical history texts to iterate into a large multimodal skin disease database.

Model: Design a deep learning network based on multi-scale and multi-level. The collaborative attention learning network realizes the collaborative representation of multi-modal data at the feature level, builds a multi-modal skin disease auxiliary diagnosis model, and realizes breakthroughs in algorithms. Develop the segmentation network of skin lesions and model for surgery planning, including surgical margin design and navigation of intraoperative sampling.

System: Propose an artificial intelligence system combined with the real-time augmented reality to assist dignosis and surgery for skin diseases.

Equipment: Based on the self-developed high-performance system, construct and assemble infrared multi-spectral skin disease auxiliary diagnosis equipment and multifunctional device for skin tumors surgery.

A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System

Based on Artificial Intelligence, Augmented Reality and New Optical Imaging Technology, the Research and Development of a Skin Diseases Intelligent Diagnosis and Treatment System: A Multi-centric Clinical Trial in China

Compare the proposed system's perfomance with the doctors in the terms of the diganosis and lesion segmentation. After using the system and the device, doctors evaluated its performance on the Skin Lesion Boundary Description, Margin Design, Sampling Navigation, Projection Effect, Security, Time-consuming and Convenience. 0-10 points for each indicator is scored independently by 4 doctors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg	NCT05451680	Skin Tumor	Negative pressu... Conventional ca...	18 Years - 110 Years	Helsinki University Central Hospital
Feasibility Trial of Diffusing Alpha-emitter Radiation Therapy (DaRT) for Malignant Skin & Superficial Soft Tissue Tumors	NCT04377360	Malignant Skin ... Soft Tissue Tum...	Diffusing Alpha...	18 Years -	Alpha Tau Medical LTD.
A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System	NCT05463523	Skin Diseases Artificial Inte... Augmented Reali... Medical Imaging	A Real-time Aug...	-	Xiangya Hospital of Central South University
A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System	NCT05463523	Skin Diseases Artificial Inte... Augmented Reali... Medical Imaging	A Real-time Aug...	-	Xiangya Hospital of Central South University

Spots Global Cancer Trial Database for skin tumor

Every month we try and update this database with for skin tumor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for skin tumor

Every month we try and update this database with for skin tumor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for skin tumor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.