Pectus DeformityNCT04885387
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
A study testing chest CT and Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device in people with Pectus Deformity, run by University Hospital, Limoges at 1 site in France.
Trial summary
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pectus Deformity
- What is being tested?
- chest CT and Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 Jun 2020
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children (< 18 years of age)
- with a pectus deformity
- recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.
In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .
Read more
The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.
The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .
- Conditions
- Pectus Deformity
- Being tested
- chest CT, Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest CTDevice
chest CT pectus deformities diagnostic
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning deviceDevice
Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic
| Study group | Role | What they receive |
|---|---|---|
| Standard protocol using chest CT | Other | Not described Receives: Device: chest CT |
| Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device | Experimental | Not described Receives: Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI)
Measured: At 12 month
Secondary outcomes (2)
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner
Measured: At 12 month
To compare the Haller Index measured with CT and the HI measured with MRI
Measured: At 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Apr 2019
- Primary completion1 Mar 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus DeformityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885387
- Sponsor's protocol ID
- Ballouhey Xray
- Status last verified
- Mar 2021
- First submitted
- 9 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device
- ClinicalTrials.gov ID
- NCT04885387
- Acronym / sponsor ID
- Ballouhey Xray
- Conditions
- Pectus Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 May 2021 (actual)
- 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.
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.
In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .
The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.
The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard protocol using chest CT | Other | Device: chest CT |
| Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device | Experimental | Device: Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children (< 18 years of age)
- with a pectus deformity
- recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest CTchest CT pectus deformities diagnostic | Device | Standard protocol using chest CT |
| Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning deviceMagnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic | Device | Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device |
Primary outcome
To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI)
Time frame: At 12 month
2 secondary outcomes
To compare the Haller Index measured with CT and the HI measured with low-cost portable three-dimensional scanner
Time frame: At 12 month
To compare the Haller Index measured with CT and the HI measured with MRI
Time frame: At 12 month
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 13 May 2021.
Related trials for Pectus Deformity
RecruitingObservational study
SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum
Pectus Excavatum, Chest Deformities
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest CT and Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device in people with Pectus Deformity, run by University Hospital, Limoges at 1 site in France.
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 3 inclusion and 1 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 13 May 2021. 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 France. 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?
To compare a standard protocol using chest CT to a non-irradiant protocol involving a low-cost portable three-dimensional scanner and MRI for all pectus deformities based on the Haller index (HI) (time frame: At 12 month). 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 13 May 2021; AzTrials last refreshed its copy on 27 Oct 2026.