[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemangioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemangioma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100629659","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-everolimus-in-patients-with-teratment-refractory-vascular-anomalies-100629659",false,"NCT07477548","A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies","Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Everolimus in Relapsed or Refractory Hemangioendothelioma and Other ISSVA Group I or II Vascular Malformation and Neoplasms","Inclusion Criteria:\n\n① Diagnosis per the 2014 ISSVA classification: Group 1 (hemangioendothelioma, tufted angioma): histologically confirmed tumor, OR Kasabach-Merritt Syndrome (histologically confirmed or histologic diagnosis not feasible) Group 2 (vascular tumors not in Group 1, or vascular malformations): histologically confirmed, OR radiologically diagnosed when biopsy is not feasible\n\n* Age ≥1 year ③ Failure of at least one prior therapy (e.g., vincristine, corticosteroids, interferon), stratified as: Cohort 1: sirolimus-naïve Cohort 2: prior sirolimus failure\n\n  * At least one measurable target lesion ≥1 cm in longest diameter per RECIST 1.1 on CT or MRI\n\n    * ECOG Performance Score 0, 1, or 2 ⑥ WOCBP must have a negative pregnancy test prior to enrollment; adequate contraception required during the study and for 8 weeks after completion ⑦ Written informed consent obtained\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding (WOCBP must use adequate contraception)\n\n  * Documented allergy or hypersensitivity to everolimus\n\n    ③ Inadequate organ function: Bone marrow: ANC \\\u003C1,000\u002FµL or platelets \\\u003C75,000\u002FµL Renal: serum creatinine \\>1.5×ULN; if \\>1.5×ULN, 24-hour creatinine clearance \\\u003C60 mL\u002Fmin Hepatic: total bilirubin \\>1.5×ULN or ALT \\>3.0×ULN\n    * KMP associated with vascular tumors or malformations is not an exclusion criterion, including: thrombocytopenia (\\\u003C100,000\u002FµL), hypofibrinogenemia, anemia (Hb \\\u003C8 g\u002FdL), consumptive coagulopathy, or overlying skin changes (edema, warmth, erythema, purplish\u002Fdark discoloration)\n\n      * Uncontrolled hyperlipidemia (fasting cholesterol \\>300 mg\u002FdL or triglycerides \\>2.5×ULN)\n\n        * Uncontrolled diabetes (fasting glucose \\>1.5×ULN)\n\n          * Active uncontrolled infection\n\n            * Hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive) ⑨ Known HIV infection (positive serology)\n\n              * Clinically significant symptomatic pulmonary dysfunction; PFTs and room air SpO₂ performed if clinically indicated; exclusion if FEV₁ ≤70% or DLCO ≤70% of predicted (assessed in patients ≥8 years)\n\n                ⑪ Prior solid organ or hematopoietic stem cell transplantation (bone marrow, liver, kidney, lung, or heart)\n\n                ⑫ Concomitant investigational agents (e.g., mTOR inhibitors: sirolimus, temsirolimus)\n\n                ⑬ Concurrent chemotherapy (e.g., mTOR inhibitors: sirolimus, temsirolimus)\n\n                ⑭ Concurrent other malignancy not meeting eligibility criteria","ALL","1 Year",{"count":19,"type":20},67,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background and Objectives Vascular anomalies are a heterogeneous group of disorders classified into vascular tumors and vascular malformations according to the ISSVA classification. Although most follow a benign course, a subset causes serious complications including organ dysfunction, chronic pain, thrombocytopenia, and hemorrhage. Kaposiform hemangioendothelioma (KHE) complicated by Kasabach-Merritt Phenomenon (KMP) carries a mortality rate of 14-24%. Surgical resection is the primary treatment when organ damage is not anticipated; however, when surgery is not feasible, pharmacologic therapy is considered. Agents such as interferon, corticosteroids, vincristine, cyclophosphamide, and propranolol have been used with variable efficacy, and no established therapy exists for patients refractory to these treatments.\n\nThe PI3K-Akt-mTOR and RAS-MEK-ERK pathways have been identified as key molecular mechanisms underlying vascular anomalies. Targeted therapies against these pathways are emerging, including anti-VEGF antibodies, PI3K\u002FAkt inhibitors (e.g., alpelisib, miransertib), and mTOR inhibitors. Sirolimus has demonstrated clinical benefit in 50-80% of patients with vascular anomalies, with a 96% symptom response rate in KMP-associated vascular tumors. Everolimus, another mTOR inhibitor, is already approved and established for tuberous sclerosis-associated angiomyolipoma and SEGA in pediatric patients, with a well-characterized safety profile. Given its shared mechanism with sirolimus and emerging case reports supporting efficacy in KHE with KMP, this phase 2 study aims to evaluate the efficacy and safety of everolimus in patients with treatment-refractory vascular anomalies.\n\nStudy Design This is a single-center, open-label, uncontrolled phase 2 clinical trial enrolling 67 patients over 60 months from IRB approval, stratified into two cohorts: Cohort 1 (sirolimus-naïve, n=39) and Cohort 2 (prior sirolimus failure, n=28). Everolimus is administered orally at age- and CYP3A4\u002FP-gp inducer-adjusted doses, with maintenance dosing titrated to a target trough level of 5-15 ng\u002FmL. The primary endpoint is overall response rate (ORR) at 6 months. Secondary endpoints include toxicity per NCI CTCAE v4.0, ORR at 12 months, platelet recovery rate at 4 weeks (KMP patients), 1-year overall survival, and 3-year progression-free survival.",[26,27,28,29,30,31,32],"Vascular Malformations","Arteriovenous Malformations","Venous Malformation","Lymphangioma","Nevus, Port-Wine","Hemangioendothelioma","Hemangioma","NOT_YET_RECRUITING","2026-03-12",{"date":36,"type":37},"2026-03-17","ACTUAL",{"date":39,"type":20},"2026-04-01",{"date":41,"type":20},"2030-11-30",{"name":43,"class":44},"Yonsei University","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100625104","fluctuational-imaging-for-the-diagnosis-of-hepatic-hemangioma-a-multicenter-prospective-study-100625104","NCT07418294","Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* Presence of a focal hepatic lesion measuring 1 cm or larger on ultrasonography.\n* Lesion diagnosis established by pathology or lesion-specific imaging reference standards, or expected to be definitively established within 1 month after the FLI examination.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to maintain stable breath-holding for at least 5 seconds during ultrasonography.\n* Inadequate B-mode ultrasound image quality of the target lesion due to factors such as acoustic shadowing or severe beam attenuation.\n* Target lesion measuring less than 1 cm on ultrasonography.\n* Failure to establish a definitive diagnosis within 1 month after the FLI examination.",true,"19 Years",{"count":54,"type":20},400,"OBSERVATIONAL","\\[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.\n\nIn 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.\n\nA 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).\n\n\\[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.\n\n\\[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.",[32],"RECRUITING","2026-02-11",{"date":61,"type":37},"2026-02-18",{"date":63,"type":37},"2026-01-02",{"date":65,"type":20},"2026-12-31",{"name":43,"class":44},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":67},"100199489","a-clinical-trial-of-pulsed-dye-laser-versus-timolol-topical-solution-versus-observation-on-the-growth-of-hemangioma-in-newborn-100199489","NCT01873131","A Clinical Trial of Pulsed-dye Laser Versus Timolol Topical Solution Versus Observation on the Growth of Hemangioma in Newborn","Preventing Growth of Hemangioma Tumors in Newborn: A Prospective Randomized Clinical Study","Inclusion Criteria:\n\n1. Subjects aged less than 3 months, male or female.\n2. Infant with one or more superficial hemangiomas in the preproliferative phase or very early proliferative growth phase.\n3. Absence or minimal appearance of the lesion at birth\n4. More pronounced appearance within 1 month of birth.\n5. Willingness of parent\u002Fguardian to participate in the study\n6. Willingness of parent\u002Fguardian to receive EXPERIMENTAL treatment\n7. Informed consent agreement signed by the parent\u002Fguardian\n8. Willingness of parent\u002Fguardian to follow the treatment schedule and post treatment care requirements\n9. Willingness of parent\u002Fguardian to not use topical or systemic (oral) TREATMENT medications of the hemangioma other than those prescribed by the investigators during the study period.\n\nExclusion Criteria:\n\n1. Infants already on other treatment prior to PDL or timolol treatments (including topical, systemic steroids or other agents)\n2. Any infant who, in the opinion of his or her pediatrician or the investigators, has a major medical problem (such as cardiac pathology or airway obstruction) that makes participation in the study difficult\n3. Infants with hemangiomas that threaten vital functions (e.g. obstructing the airway or impairing hearing or vision)\n4. Scarring or infection of the area to be treated\n5. Subjects who are immunocompromised\n6. Subject whose parent\u002Fguardian is unable to comply with treatment, home care or follow-up visits\n7. Patients with asthma or a history of asthma, chronic obstructive pulmonary disease or cardiovascular disease, including sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock; hypersensitivity to any component of timolol; and in those patients receiving systemic administration of beta-blockers or ace inhibitors.","3 Months",{"count":77,"type":20},126,[79],"NA","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.\n\nHemangioma 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.\n\nPulsed dye laser is widely used in children, and is approved by the U.S. Food and Drug Administration (FDA) for treating hemangioma.\n\nThe 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.\n\nAn 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.",[32],[83,84,85,86,87,88,89],"hemangioma","infantile hemangioma","pulsed dye laser","PDL","topical beta blocker","timolol maleate","timolol","2023-11-01",{"date":92,"type":37},"2023-11-02",{"date":94,"type":4},"2011-02",{"date":96,"type":20},"2028-12",{"name":98,"class":44},"Massachusetts General Hospital"]