Clinical trial · Observational
Optical Tomographic Imaging of Infantile Hemangiomas
NCT01673971CI-TRIAL-00034139completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators hypothesize that there are differences between infantile hemangiomas (IH) during the proliferating and involuting phases and in response to medical treatment that can be detected by optical tomography of these hemangiomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infantile Hemangioma | Infantile Hemangioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Natural History
- label
- Treatment
Primary outcomes (2)
- measure
- Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
- timeFrame
- Up to 2 years
- description
- Measurements of absolute total hemoglobin concentration (\[THb\]) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
- measure
- Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
- timeFrame
- Up to 2 years
- description
- Measurements of tissue oxygen saturation (StO2) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 7 Years
Show eligibility criteria text
For the 'Natural History' Cohort, the following inclusion and exclusion criteria apply: INCLUSION CRITERIA: * Infants with IH who present to our practices within the first 2 months of life. * IH of size \> 2 cm in diameter * IH located on area of skin that is accessible to contact by 4x2cm probe. Examples include the lateral face, forehead, scalp, trunk and areas of the extremities not overlying joints. Infants with IH that do not necessitate either medical or surgical intervention at time of presentation. EXCLUSION CRITERIA: * IH of size \<2 cm in diameter * Complicated IH requiring medical or surgical intervention * IH located within 2 cm of the eye For the 'Treatment' Cohort, the following inclusion and exclusion criteria apply: INCLUSION CRITERIA: * Infants with IH who present to our practices within the first 2 months of life. * IH of size \>2 cm in diameter * IH located on area of skin that is accessible to contact by 4x2cm probe. Examples include the lateral face, forehead,scalp, trunk and areas of the extremities not overlying joints. * IH that necessitate medical intervention with either oral or topical betablockers. EXCLUSION CRITERIA: * IH \<2 cm in size * Complicated IH requiring surgical intervention * IH located within 2 cm of the eye
References
Publications (0)
Data not yet available
No reference posted for this study.