West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Location contact
Ji Yi, MD
PRINCIPAL_INVESTIGATOR
Yi Ji MD, PhD
CONTACT
zhang kai zhi, MD
SUB_INVESTIGATOR
NCT Number: NCT07616323
The objective of this study is to determine the maximal diameter threshold at which infants with lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb extending infantile hemangiomas should undergo screening for LUMBAR syndrome.
Trial opening soon.
Get Notified0 year–10 year
All sexes
Observational
Chengdu, Sichuan, 610041, China
Ji Yi, MD
PRINCIPAL_INVESTIGATOR
Yi Ji MD, PhD
CONTACT
zhang kai zhi, MD
SUB_INVESTIGATOR
Infantile hemangiomas located in the lumbosacral, sacrococcygeal, perineal, gluteal, or lower-limb-extending regions may be associated with LUMBAR syndrome. LUMBAR syndrome refers to a spectrum of regional congenital anomalies associated with lower-body infantile hemangiomas, including lower-body hemangioma, urogenital anomalies, ulceration, myelopathy or spinal dysraphism, bony deformities, anorectal malformations, arterial anomalies, and renal anomalies.
However, the optimal lesion size threshold for initiating systematic screening remains unclear. In current clinical practice, some patients with large or segmental hemangiomas undergo magnetic resonance imaging and systemic evaluation, whereas others with smaller but potentially high-risk lesions may not be screened. Therefore, a clinically practical and evidence-based diameter threshold is needed to guide LUMBAR syndrome screening.
Previous prospective evidence has suggested that lumbosacral infantile hemangiomas larger than 2.5 cm may be associated with a high rate of spinal anomalies. However, whether this 2.5-cm threshold applies to hemangiomas involving the sacrococcygeal, perineal, gluteal, or lower-limb-extending regions remains uncertain. Therefore, this study aims to prospectively evaluate the relationship between maximal lesion diameter and LUMBAR-associated anomalies and to identify an optimal screening threshold.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Screening for LUMBAR syndrome by MRI
Time frame: 2 weeks
LUMBAR-associated anomalies include spinal or spinal cord anomalies, urogenital anomalies, renal anomalies, anorectal malformations, bony deformities, arterial anomalies, or other regional developmental abnormalities consistent with the LUMBAR spectrum.
Time frame: 2 weeks
Time frame: 2 weeks
Time frame: 6 months
Contact information is provided by the study sponsor or research team.
West China Hospital
Other
Diameter Threshold for Screening LUMBAR Syndrome in Infants With Lumbosacral, Sacrococcygeal, Perineal, and Gluteal Infantile Hemangiomas: A Prospective Multicenter Cohort Study
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