Infantile HemangiomaNCT01673971
Optical Tomographic Imaging of Infantile Hemangiomas
An observational study of Infantile Hemangioma, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Infantile Hemangioma
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: All subjects will be recruited verbally from the pediatric dermatology faculty practices, clinics and inpatient services at CUMC/NYP (MSCHONY). In accordance with CUMC policy, researchers will not approach a patient for recruitment until that patient has been informed of the study by their treating physician who has ascertained the patient's willingness to discuss the study with the investigators.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
- IH <2 cm in size
- Complicated IH requiring surgical intervention
- IH located within 2 cm of the eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center / Department of Dermatology
New York, New York, 10032
About this study
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.
Read the detailed description
Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The clinical presentation is variable, and some hemangiomas have the potential to cause disfiguring and even lifethreatening complications. While there is no FDA approved treatment for IH, certain medications have been shown to be effective in shrinking the growths. Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool would improve the management of these patients. A new handheld wireless device uses diffuse optical imaging (DOI) technology to measure blood flow characteristics.
The device has been used in studies to assess patients with breast cancer. Optical tomography has also been increasingly used to assess neurological function and pathology in newborn infants.
The goal of the investigators' study is to assess the utility of DOI for characterizing and monitoring IH. Fifteen IH will be assessed at three points in time as part of this study, comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated with clinical findings and existing ultrasound measurements of the IH.
- Conditions
- Infantile Hemangioma
- Keywords
- hemangioma
- Medical subject headings
- Hemangioma, Capillary, Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Natural History | Not described | |
| Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
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.
Measured: Up to 2 years
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
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.
Measured: Up to 2 years
Secondary outcomes (2)
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.
Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.
Measured: Up to 2 years
Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.
Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startMay 2012
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile HemangiomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Garzon, Columbia University
- Investigators
- Maria Garzon, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673971
- Sponsor's protocol ID
- AAAJ1201
- Status last verified
- Aug 2018
- First submitted
- 24 Aug 2012
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Tomographic Imaging of Infantile Hemangiomas
- ClinicalTrials.gov ID
- NCT01673971
- Acronym / sponsor ID
- AAAJ1201
- Conditions
- Infantile Hemangioma
- Keywords
- hemangioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The clinical presentation is variable, and some hemangiomas have the potential to cause disfiguring and even lifethreatening complications. While there is no FDA approved treatment for IH, certain medications have been shown to be effective in shrinking the growths. Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool would improve the management of these patients. A new handheld wireless device uses diffuse optical imaging (DOI) technology to measure blood flow characteristics.
The device has been used in studies to assess patients with breast cancer. Optical tomography has also been increasingly used to assess neurological function and pathology in newborn infants.
The goal of the investigators' study is to assess the utility of DOI for characterizing and monitoring IH. Fifteen IH will be assessed at three points in time as part of this study, comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated with clinical findings and existing ultrasound measurements of the IH.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural History | – | – |
| Treatment | – | – |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All subjects will be recruited verbally from the pediatric dermatology faculty practices, clinics and inpatient services at CUMC/NYP (MSCHONY). In accordance with CUMC policy, researchers will not approach a patient for recruitment until that patient has been informed of the study by their treating physician who has ascertained the patient's willingness to discuss the study with the investigators.
Key inclusion criteria (8 listed)
- 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.
- Infants with IH who present to our practices within the first 2 months of life.
Key exclusion criteria (7 listed)
- IH of size <2 cm in diameter
- Complicated IH requiring medical or surgical intervention
- IH located within 2 cm of the eye
- IH <2 cm in size
- Complicated IH requiring surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
Time frame: Up to 2 years
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.
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
Time frame: Up to 2 years
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.
2 secondary outcomes
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.
Time frame: Up to 2 years
Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Garzon, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Hemangioma, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin. (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.