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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LUMBAR Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | Screening for LUMBAR syndrome by MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the presence of at least one LUMBAR-associated structural anomaly detected by standardized screening. | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of infants clinically diagnosed with infantile hemangioma involving the lower-body region, including the lumbosacral, sacrococcygeal, gluteal, perineal, perianal, external genital, or continuously extending lower-limb areas. Eligible patients will be prospectively and consecutively recruited from participating centers. The target population is selected because infantile hemangiomas in these anatomical regions, particularly large or segmental lesions, may be associated with LUMBAR syndrome or LUMBAR-associated structural anomalies.
Patients with a maximal lesion diameter of ≥2.0 cm will be included in order to allow evaluation of different candidate screening thresholds. The 2.0-cm cutoff will serve as the enrollment threshold rather than the final screening threshold. This design enables comparison of clinically relevant candidate cutoffs, including ≥2.0 cm, ≥2.5 cm, ≥3.0 cm, ≥4.0 cm, and ≥5.0 cm, for predicting LUMBAR-associated anomalies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ji MD, PhD | Contact | 86 28 85423453 | jijiyuanyuan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42021702 | Result | 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. | |
| 41366822 | Result | 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. |
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| ID | Term |
|---|---|
| D013577 | Syndrome |
| D018324 | Hemangioma, Capillary |
| ID | Term |
|---|---|
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006391 | Hemangioma |
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| 2 weeks |
| Proportion of patients requiring further specialist treatment or intervention. | 6 months |
| 40963452 | Result | 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. |
| 30584062 | Result | 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. |
| 20828712 | Result | 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. |
| 38759778 | Result | 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. |
| 20598318 | Result | 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. |
| D009383 |
| Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |