A Pilot Study of the Treatment of Facial Nodular and Nodulocystic Basal Cell Carcinoma With Double...
Basal Cell CarcinomaThe purpose of this study is to determine recurrence rates of nodular Basal Cell Carcinomas on the face removed with curettage and electrodessication (cautery) followed by application of Imiquimod cream to the base and further to achieve lower recurrence rates than after treatment with curettage and electrodessication alone.
Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study
Basal Cell Carcinoma (BCC)A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery. 10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
Study Assessing the Safety and Performance of Smart Matrix®
Basal Cell CarcinomaSquamous Cell CarcinomaSmart Matrix is a sterile, single layer dermal replacement scaffold. The scaffold consists of a porous matrix of cross-linked human fibrin plus alginate that has been designed and optimised to facilitate wound closure and healing through cellular invasion.
Superficial Basal Cell Carcinoma Treatment With Topical Photodynamic Therapy With Fractionated 5-aminolevulinic...
Superficial Basal Cell CarcinomaSkin cancer is the most common cancer in Caucasians, and a basal cell carcinoma (BCC) being the most common skin cancer with around 44,000 new tumours per year, and its incidence is still rising. In the past it has been a disease of the elderly patient but as a consequence of recreational sun exposure and tanning beds, more young patients develop a skin cancer as well. There are different subtypes of BCC and most subtypes are treated by surgical excision. Nowadays, non-invasive techniques as photodynamic therapy (PDT) are common practice to treat superficial BCC (sBCC). Because of these techniques treatment by surgical excision can be avoided with the possibility of complications and scar formation. Both 5-aminolevulino acid (5-ALA) and the more lipophilic methyl aminolevulinate (MAL) can be used as a precursor of the photosensitiser. These agents generate an excess of protoporphyrin IX in metabolic active cells, which are illuminated by a specific light source leading to release of reactive oxygen radicals in tissue. The result is apoptosis and necrosis of tumour cells. At the moment, two treatment protocols are used in the Netherlands: the fractionated 5-ALA 20% (Fagron) protocol according to de Haas and the MAL (Metvix, Galderma) protocol. Because MAL was first marketed and registered as a treatment option for premalignant and superficial malignancies most hospitals in the Netherlands use this topical agent. However, there is no evidence which of the 2 agents is more (cost-)effective and/ or preferred by patients. Objective: to determine which treatment is the most effective treatment in terms of prevention of treatment failure, cost saving and patients preference when comparing fractionated 5-ALA 20% PDT versus MAL PDT in 2 treatment sessions.
Laser Immunotherapy With and Without Topical Anti-PD1 in Basal Cell Carcinomas
BCC - Basal Cell CarcinomaImmune Response2 moreThe study aim is to assess the immunological and clinical response in basal cell carcinoma (BCC) treated with ablative fractionated laser (AFL) as monotherapy and compare with BCC treated with combination-therapy of AFL and the anti-PD1-drug nivolumab and with nivolumab as monotherapy.
An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal...
Basal Cell CarcinomaThis multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.
EPR Tumor Oximetry With CE India Ink
NeoplasmsMalignant8 moreIt has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising. The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes. The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.
Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Melanoma (Skin)Basal Cell Carcinoma6 moreThe purpose of this clinical study is to evaluate if the DermaSense prototype EIS scanner can provide medical decision support which can complement dermoscopy-based identification of the disease at time of biopsy decision.
Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer
Non-melanoma Skin CancerBasal Cell Carcinoma1 moreThis study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma).
Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma...
Nodular Basal Cell CarcinomaBasal cell carcinoma (BCC) is a slow-growing, locally invasive malignant epidermal skin tumour. It is the most common malignant disease in Caucasians, representing approximately 80% of all cases of skin cancer and is therefore an important health problem. In the Netherlands incidence rates are 165 for men and 157 for women per 100.000 person-years, and these rates are rising with 3-10% every year. A simplified histological classification of BCCs includes the following three subtypes: nodular, superficial and infiltrative variants, with the nodular variant being the most frequent type. Although a characteristic feature of BCCs is their low risk to metastasize, if untreated they may be locally invasive and may induce considerable functional and cosmetic morbidity. The gold standard treatment of all histological BCC subtypes is surgical excision (SE), but not all patients are eligible for surgery. In patients with multiple BCCs and older patients, surgery may lead to significant morbidity, and in some cases, it may result in disfiguring scarring. For these reasons and to reduce workload and costs in the healthcare system, there is a growing demand for alternative, non-invasive, treatments. An advantage of non-invasive treatment options is that they can be performed by other healthcare professionals, such as general practitioners and specialized nurses. For treatment of superficial BCCs (sBCC) non-invasive treatments, such as topical imiquimod (IMQ), 5-fluorouracil (5-FU) or photodynamic therapy (PDT) are already commonly used. Our group investigated the efficacy of those three therapies and found that after 3 years, BCCs treated with IMQ had a significant lower risk of recurrence, compared to the other therapies. A recent study suggests that IMQ, besides being an immune-response modifier, also directly inhibits sonic hedgehog (SHH) signalling, the most important pathway active in BCCs. This targeted effect of IMQ very likely explains the superior therapeutic effect. Treatment of nodular BCC (nBCC) with IMQ has been investigated. Without prior curettage, high efficacy rates were found, although efficacy was still slightly inferior to SE. The investigators hypothesize that the effectiveness of IMQ following prior curettage will not be inferior to SE and that the benefits will be a higher patient satisfaction and lower healthcare costs. A recently published discreet choice experiment showed that patients preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment.