Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas

NCT07616323 | Not Yet Recruiting DMC

• 1 other identifier: 20260522
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

LUMBAR Syndrome

Keywords

LUMBAR syndrome; screening; infantile hemangioma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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.

  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.

  2 weeks

• Proportion of patients requiring further specialist treatment or intervention.

  6 months

Study Arms (1)

LUMBAR Syndrome

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Screening for LUMBAR syndrome by MRI

LUMBAR Syndrome

Eligibility Criteria

• Age: 0 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (7)

• 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 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.

  PMID: 41366822 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.

  PMID: 40963452 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.

  PMID: 30584062 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.

  PMID: 20828712 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.

  PMID: 38759778 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.

  PMID: 20598318 RESULT

MeSH Terms

Conditions

Syndrome; Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yi Ji MD, PhD

CONTACT

86 28 85423453; jijiyuanyuan@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)