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Not yet recruiting NCT07616323

Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas

— Observational LUMBAR Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: LUMBAR Syndrome. Basic parameters: 0 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Diameter Threshold for Screening LUMBAR Syndrome in Infants With Lumbosacral, Sacrococcygeal, Perineal, and Gluteal Infantile Hemangiomas: A Prospective Multicenter Cohort Study

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test MRI
    Screening for LUMBAR syndrome by MRI

Primary outcome measures

  • The primary outcome will be the presence of at least one LUMBAR-associated structural anomaly detected by standardized screening. [Time frame: 2 weeks]
Secondary outcome measures (3)
  • Detection rate of spinal or spinal cord anomalies.Detection rate of anorectal, perineal, or urogenital anomalies. Detection rate of arterial or lower-limb developmental anomalies. [Time frame: 2 weeks]
  • Detection rate of renal or urinary tract anomalies.Detection rate of LUMBAR-associated anomalies according to lesion location.Detection rate according to lesion diameter category. [Time frame: 2 weeks]
  • Proportion of patients requiring further specialist treatment or intervention. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Clinically diagnosed infantile hemangioma.
  • Lesion located in at least one of the following regions: lumbosacral region, sacrococcygeal region, gluteal region, perineal region, perianal region, external genital region, or continuous extension to the lower limb.
  • Maximal lesion diameter ≥2.0 cm.
  • Written informed consent obtained from the parents or legal guardians.

Exclusion criteria

  • Vascular anomaly other than infantile hemangioma, such as venous malformation, lymphatic malformation, arteriovenous malformation, or congenital hemangioma.
  • Previously diagnosed genetic or congenital syndrome unrelated to LUMBAR syndrome, which may independently explain the detected anomalies.
  • Incomplete clinical data preventing accurate measurement of lesion diameter.
  • Refusal of participation or refusal to complete core screening examinations.
  • Any condition judged by the investigators to be unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • West China Hospital of Sichuan University — Chengdu

Publications

  • Metry D, Fernandez-Faith E, Haggstrom A, Keppler-Noreuil K, Frieden IJ. Segmental Infantile Hemangiomas That Involve the Midline Define Risk for LUMBAR Syndrome. Pediatr Dermatol. 2026 Apr 23. doi: 10.1111/pde.70178. Online ahead of print. PMID 42021702
  • Bhatta D, Dev A, Chatterjee D, De D. Extensive Lower Body Infantile Hemangioma With Ulcerations, Spinal and Genitourinary Anomalies: A Case of LUMBAR Syndrome. Int J Dermatol. 2026 Jun;65(6):1300-1302. doi: 10.1111/ijd.70198. Epub 2025 Dec 9. No abstract available. PMID 41366822
  • Martin B, Bui JK, Corpin A, Siegel DH, Metry DW. LUMBAR Syndrome State-Of-The-Art Review: Insights Into a Rare and Complex Condition. Pediatr Dermatol. 2025 Nov-Dec;42(6):1117-1125. doi: 10.1111/pde.70024. Epub 2025 Sep 18. PMID 40963452
  • Krowchuk DP, Frieden IJ, Mancini AJ, Darrow DH, Blei F, Greene AK, Annam A, Baker CN, Frommelt PC, Hodak A, Pate BM, Pelletier JL, Sandrock D, Weinberg ST, Whelan MA; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475. doi: 10.1542/peds.2018-3475. PMID 30584062
  • Drolet BA, Chamlin SL, Garzon MC, Adams D, Baselga E, Haggstrom AN, Holland KE, Horii KA, Juern A, Lucky AW, Mancini AJ, McCuaig C, Metry DW, Morel KD, Newell BD, Nopper AJ, Powell J, Frieden IJ. Prospective study of spinal anomalies in children with infantile hemangiomas of the lumbosacral skin. J Pediatr. 2010 Nov;157(5):789-94. doi: 10.1016/j.jpeds.2010.07.054. Epub 2010 Sep 9. PMID 20828712
  • Metry D, Copp HL, Rialon KL, Iacobas I, Baselga E, Dobyns WB, Drolet B, Frieden IJ, Garzon M, Haggstrom A, Hanson D, Hollenbach L, Keppler-Noreuil KM, Maheshwari M, Siegel DH, Waseem S, Dias M. Delphi Consensus on Diagnostic Criteria for LUMBAR Syndrome. J Pediatr. 2024 Sep;272:114101. doi: 10.1016/j.jpeds.2024.114101. Epub 2024 May 15. PMID 38759778
  • Iacobas I, Burrows PE, Frieden IJ, Liang MG, Mulliken JB, Mancini AJ, Kramer D, Paller AS, Silverman R, Wagner AM, Metry DW. LUMBAR: association between cutaneous infantile hemangiomas of the lower body and regional congenital anomalies. J Pediatr. 2010 Nov;157(5):795-801.e1-7. doi: 10.1016/j.jpeds.2010.05.027. Epub 2010 Jul 2. PMID 20598318

Identifiers

NCT: NCT07616323 · 20260522

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗