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Showing 1-20 of 23 trials
NCT07418294
\[Background and Rationale\] Hepatic hemangioma is the most common benign tumor of the liver, with a reported prevalence of up to 20% in the general population. On B-mode ultrasonography, a typical hemangioma appears as a well-defined hyperechoic lesion compared with the surrounding liver parenchyma. However, hyperechogenicity is observed in only approximately 70% of cases, while the remaining lesions may appear hypoechoic or mixed echogenic. Additional sonographic features such as posterior acoustic enhancement or an echogenic rim may aid diagnosis, but none are specific to hemangioma. Consequently, contrast-enhanced CT or MRI is commonly required for definitive diagnosis, even when a hemangioma is strongly suspected on conventional ultrasound. In 2020, Kobayashi et al. (Ultrasound Med Biol 2021;47:941-946)reported a novel ultrasound finding termed the "fluttering sign," defined as continuous motion of tiny hyperechoic dots within a hemangioma during real-time scanning. Although the precise mechanism has not been experimentally validated, this phenomenon is presumed to reflect motion of acoustic scatterers, mainly red blood cells, induced by the ultrasound beam. The fluttering sign was observed in approximately 39% of hyperechoic hemangiomas and in up to 85% of hypoechoic or mixed-echoic hemangiomas, suggesting potential lesion specificity. A major limitation of the fluttering sign is its subjectivity, as visual assessment during real-time ultrasound is highly operator-dependent. To address this limitation, Imamura et al. (Sci Rep 2022;12:4701) developed a computer-based algorithm named Fluctuational Imaging (FLI), which objectively quantifies fluttering motion. FLI demonstrated almost perfect agreement with visual assessment of the fluttering sign (Cohen's kappa = 0.95). \[Study Objectives\] Although FLI is theoretically expected to be specific to hemangiomas, no study has systematically evaluated its behavior across a broad spectrum of non-hemangioma hepatic lesions. The primary objective of this study is to investigate whether the proportion of FLI-positive findings is significantly higher in hepatic hemangiomas than in non-hemangioma liver lesions. \[Risk-Benefit Assessment\] FLI is based on conventional diagnostic ultrasound physics and does not impose additional risk to patients. If FLI enables confident diagnosis of hepatic hemangioma using ultrasound alone, it may reduce unnecessary contrast-enhanced CT or MRI examinations, thereby decreasing healthcare costs, radiation exposure, and contrast-related risks. Overall, the anticipated benefits outweigh potential risks.
NCT02625389
This was a multicenter phase IV Post-Marketing Study. The study is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical glues used according to each site medical practice of vascular embolization. Subjects will be enrolled with the main condition that a procedure of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues is part of their therapeutic/palliative strategy for their disease. The vascular embolization using Lipiodol® Ultra Fluid in association with surgical glue will be administered as study procedure. According to the patient need and health status a second vascular embolization using Lipiodol® Ultra Fluid in association with surgical glue may be considered by the investigator within the next 30 days after the first one. In this case, this procedure will be considered as a second study procedure. The per-procedure safety evaluation will be enabled by appropriate records of safety events during the time frame of the procedure of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues. Safety evaluation will be completed with safety records within 30 +/-3 days after the embolization procedure. Efficacy evaluation will rely on the level of lesion(s) obliteration after embolization compared to the pre-procedural target level of obliteration. Exploratory descriptive statistical methods will be used to evaluate safety and efficacy, using both the total population and subsets of subjects with similar clinical conditions.
NCT01764529
Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. CCMs are often caused by an inherited gene mutation (alteration) in one of three CCM genes (CCM1, CCM2, or CCM3). There is a wide range of disease severity even among family members with this disease, though the natural history has not been clearly described for this particular population. This study will continue to enroll and follow participants with familial CCM to identify factors that influence CCM disease severity and progression, focusing on barriers to clinical trial preparedness. Our long-term goal is to identify measurable outcomes and robust biomarkers that will help select high-risk patients and help monitor drug response in future clinical trials. The specific goals of this study are to: * Identify factors that influence lesion progression to symptomatic hemorrhage and other outcomes, including quality of life; * Investigate the role of the gut microbiome and lesion burden in CCM disease, and * Identify blood biomarkers predictive of CCM disease severity and progression for clinical trials.
NCT06130436
Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.
NCT01873131
The purpose of this study is to find out if pulsed dye laser treatment or timolol maleate 0.5% gel can help infants who have a hemangioma. The investigators also want to find out if pulsed dye laser treatment and timolol maleate 0.5% gel are safe to use without causing too many side effects. Hemangioma is a common type of birthmark. These birthmarks happen when many new blood vessels grow in a specific area on the skin. Blood vessels are tiny tubes that carry blood through the body. No one knows what causes blood vessels to group together. Most birthmarks don't hurt at all and they usually aren't a sign of any kind of illness. Lots of newborns have these birthmarks on their bodies, like between the eyebrows. These birthmarks usually disappear within the first few months to years of life. These birthmarks tend to disappear spontaneously. Most hemangiomas are not treated unless the hemangioma threatens the child's health, which occurs in about 1 in 3 children with hemagiomas. Pulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma. The FDA has approved timolol maleate to treat glaucoma in adults, but the FDA has not approved timolol maleate to treat hemangiomas in children. About 7 infants with hemangiomas have received timolol maleate. The results so far show that timolol maleate may be helpful and safe in treating hemangiomas in infants. An important question being tested in this study is whether pulsed-dye laser or timolol maleate can prevent hemangioma from growing when used very early after birth.
NCT04077515
to evaluate the safety and efficacy of Low-dose sirolimus in Kaposiform Hemangioendothelioma in Chinese children by a prospective, randomized open trial.
NCT00540566
This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.
NCT05106179
Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal. This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.
NCT01010308
The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy. The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.
NCT04105517
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months . Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations. Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake. In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important. The selected indication concerns children from 5 weeks to 5 months with: * Hemangiomas leading to a vital or functional risk, * Hemangiomas ulcerated painful and / or not responding to simple care, * Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ". The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.
NCT04076449
Cerebral cavernous malformation (CCM)-related epilepsy (CRE) impairs the quality of life in patients with CCM. Patients could not always achieve seizure freedom after surgical resection of the lesion, suggesting an inadequate treatment and evaluation of the epileptogenic zone or network. Iron deposition in cerebral cavernous malformations has been postulated to play an important role in triggering CRE. Quantitative susceptibility mapping (QSM), as an optimal in vivo imaging technique to quantify iron deposition, is employed to analyze the iron quantity in CCM patients with epilepsy and further combined with brain structural and connectome analysis, to describe the difference between CCMs with and without epilepsy. In vivo biomarkers predicting CRE risk in CCM natural history and CRE control outcome after CCM surgical resection will be further identified to improve management strategy.
NCT01908972
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
NCT02731287
Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.
NCT00312520
The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.
NCT00466375
The purpose of this study is to determine if there are genes that are common in children with infantile hemangioma. This information will allow physicians to improve care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding the cause of this disease. This research is being done because many unanswered questions remain regarding children with infantile hemangioma. There are very few medications to treat infants with hemangiomas.
NCT02145884
We plan to conduct a study, to see how safe and effective timolol maleate 0.5% gel-forming solution is for infantile hemangiomas (IH) and the response of hemangiomas to timolol maleate 0.5% . Our hypothesis is that timolol will inhibit and possibly reverse growth of appropriate infantile hemangiomas.
NCT00967226
Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.
NCT01785212
The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic resection in our center. Recently a stapler-hepatectomy methods has been developed and approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this method is a potential shorter transection time compared to the CUSA technique. Thus the investigators will perform a randomized controlled trial including 20 patients in the stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration, T cell subsets, blood loss, morbidity, and a cost analysis.
NCT01072045
Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm. Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be defined amongst indications for treatment: patients with absolute indication for treatment and patients with relative indication for treatment. Absolute or emergency indications comprise function or life threatening situations such as obstruction of airways, obstruction of vision, congestive heart failure, hepatic and coagulation problems. The following are considered relative indications: cases of large and disfiguring facial hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip, glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more probable to scar); local complications such as ulceration, infection and bleeding as well as small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease of excision2,7. Treatment modalities vary according to the extension, location, presence of complications and the evolutional phase. A combination of various treatments is possible. Beta blockers are being used in children for approximately 40 years, with proven clinical safety and no cases of death or cardiovascular disease resulting from its direct use. Recently it was reported the use of beta blockers (propanolol) for IH treatment, with significant reduction of tumor volume after introduction of the beta blocker, in a short period of time, with stable results after the end of treatment, which suggested evidences of the benefits of this drug in the tumor treatment The proposal of this study is to assess the use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous monitoring and comparing it to the use of oral corticosteroid. The investigators propose the assessment of the betablockers' use in comparison to the use of corticosteroids in infants with IH in the proliferative or involuting phases, with indication for clinical treatment, and that are not alarming nor urgent; in other words, the current relative indications for treatment.
NCT01408056
The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.