Screening LUMBAR Syndrome in Infants With Infantile Hemangiomas

May 29, 2026 updated by: Yi Ji, West China Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
        • Contact:
        • Sub-Investigator:
          • zhang kai zhi, MD
        • Principal Investigator:
          • Ji Yi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Clinically diagnosed infantile hemangioma.
  2. 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.
  3. Maximal lesion diameter ≥2.0 cm.
  4. Written informed consent obtained from the parents or legal guardians.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LUMBAR Syndrome
Diagnostic test: MRI
Screening for LUMBAR syndrome by MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be the presence of at least one LUMBAR-associated structural anomaly detected by standardized screening.
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 2 weeks
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
2 weeks
Proportion of patients requiring further specialist treatment or intervention.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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