Diseases and Abnormalities at or Before Birth

All Conditions

Neoplasms

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Congenital Abnormalities

Teratoma

Cysts

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Epidermal Cyst

Dermoid Cyst

Thyroglossal Cyst

Pathological Conditions, Anatomical

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Skin Abnormalities

Skin Diseases

Familial Thyroglossal Duct Cyst

The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.

Different machine learning and deep learning computer aided strategies for model construction and validation.

Artificial Intelligence Algorithm

Yuhan Yang, MD

The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical information and radiological images in children.

This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available radiological images from June 2010 and December 2020. The investigators have constructed deep learning and machine learning diagnostic models on this retrospective cohort and validated it internally. A prospective cohort would recruit patients found neck masses since January 2021. The proposed computer aided diagnostic models would also be validated in this prospective cohort externally. The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for neck masses using machine learning and deep learning techniques on clinical data and radiological images in children.

Computer Aided Tool for Diagnosis of Neck Masses in Children

The diagnostic accuracy of neck masses with AI-based screening tools in children.

The diagnostic sensitivity of neck masses with AI-based screening tools in children.

The diagnostic specificity of neck masses with AI-based screening tools in children.

The diagnostic positive predictive value of neck masses with AI-based screening tools in children.

The diagnostic negative predictive value of neck masses with AI-based screening tools in children

West China Hospital

Associate Professor

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Timolol

Maleic acid

Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.

One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.

No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.

Marty O Visscher, PhD

Denise Adams, MD

Adrienne Hammill, MD, PhD

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas

IH height and volume will be obtained from surface scans with the Artec scanner with a 0.5 mm resolution, 0.1 mm accuracy, at 60 cm. Three dimensional scans will be created with the Artec Studio software and features quantified with the three dimensional software. Soft tissue landmarks will create the region of interest for all evaluations. Height and volume will be calculated for the infantile hemangioma versus the control.

Temperature information will be acquired with a thermal imaging camera with analysis software. The thermal features of the surrounding uninvolved control skin are removed by applying thresholds. Static infrared thermography captures the steady-state condition and spatial distribution. Dynamic infrared thermography applies a stress (cooling) to stimulate the thermal response within the tissue.

High resolution color Images will be taken taken with a digital camera, Micro 60 mm lens with a wireless close up flash system at 30cm and perpendicular to the site. The images are color corrected and processed into three distinct images : red color, blue-yellow color, and lightness (white - back).

Color and thermal images are co-registered and analyzed with customized software. The system creates quantitative outputs and maps for visualization of IH regions of thermal and color activity. Threshold values for the lightness, red color, blue color and thermal images are selected based upon histogram distributions of the uninvolved skin as the values above the mean and multiple standard deviations The pixels beyond the thresholds are used to quantify and map the features due to the hemangioma itself.

Tissue mechanical properties (i.e., elasticity, elastic deformation, laxity, stiffness, etc.) will be measured to assess tissue deformability. The instrument measures biomechanical properties of the skin by applying a negative pressure, in the range between 20 and 500 mbar. These properies are compared to an uninvolved contralateral control site.

Society for Pediatric Dermatology

Children's Hospital Medical Center, Cincinnati

Heart and Blood Diseases

Ulcer

Vascular Malformations

Pharmaceutical Solutions

Anti-Infective Agents

Adrenergic beta-Antagonists

Mupirocin

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Anti-Bacterial Agents

Enzyme Inhibitors

Half of enrolled subjects will receive topical Timolol

Half of enrolled subjects will receive Mupirocin

Dose-based escalation schedule for topical application:

4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day

8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day

Timolol 0.5% Gel Forming Solution (GFS)

Topical application twice per day for 60 days

Mupirocin 2% Ointment

Albert C. Yan, MD

Vikash S. Oza, MD

Patrick McMahon, MD

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.

Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.

In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.

The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.

In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.

Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)

The Efficacy of Timolol 0.5% Gel Forming Solution for the Treatment of Ulcerated Hemangiomas

A scoring system developed to measure clinical improvement of ulcerated hemangioma.

Glucose monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Glucose values \< 60 mg/dL will be considered significant.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Blood pressure monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Blood pressure values \< 3rd percentile (systolic or diastolic) will be considered significant for hypotension.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Pain will be assessed using the Wong-Baker faces scale.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of drainage or exudate, and/or culture positivity.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Investigators will question caregivers about common complications of ulcerated hemangiomas (pain, infection, bleeding) at each visit throughout the study. Infection will be clinically assessed by presence of active bleeding.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Glucose and vital sign monitoring will be performed for patients receiving Timolol 0.5% GFS before and 1 hour after drug is applied in clinic.

Heart rate values \< 3rd percentile will be considered significant and indicative of bradycardia.

Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Computer Aided Tool for Diagnosis of Neck Masses in Children	NCT05187923	Neck Mass Thyroglossal Du... Branchial Cleft... Dermoid and Epi... Infantile Heman... Teratomas	Artificial Inte...	0 Years - 18 Years	West China Hospital
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)	NCT01408056	Infantile Heman...	Timolol 0.5% Ge... Mupirocin 2% Oi...	1 Month - 8 Months	Children's Hospital of Philadelphia
Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities	NCT02061735	Infantile Heman...		1 Month - 5 Years	Children's Hospital Medical Center, Cincinnati
Computer Aided Tool for Diagnosis of Neck Masses in Children	NCT05187923	Neck Mass Thyroglossal Du... Branchial Cleft... Dermoid and Epi... Infantile Heman... Teratomas	Artificial Inte...	0 Years - 18 Years	West China Hospital

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