MalformationIMAG2NCT06224985
Computational Anatomy in Surgery for Childhood Tumours and Malformations
An observational study of Malformation and Tumor, run by Imagine Institute at 1 site in France.
Trial summary
This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech. Read more about this study
- Who is it for?
- Ages 5 months to 17 years
- Conditions the study is for
- Malformation, Tumor, Paediatric Surgery
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2016to 15 Apr 2021
- 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 5 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients included in the three groups are followed in the visceral surgery department of Necker-Enfants Malades Hospital in Paris (France) for whose an MRI is required as part of diagnosis, extension assessment or monitoring.
To be included, patients must meet the following criteria:
- Patient aged between 5 months and 17 years
- Patient with a confirmed diagnosis of :
- Abdomino-pelvic tumour
- Pelvic malformation
- Patient whose parents or legal guardians have read, accepted and signed the study consent form
- Patients whose parents or legal guardians are beneficiaries of a social security scheme.
To be included, control patients (patients other than those suffering from an abdomino-pelvic tumour or malformation) must meet the following criteria:
- Patient aged between 5 months and 17 years inclusive.
- A patient being followed in the visceral surgery department for a pathology other than tumour or malformation, and requiring MRI as part of his or her diagnosis, extension assessment or monitoring.
- Patient whose parents or legal guardians have read, accepted and signed the study consent form.
- Patient whose parents or guardians are beneficiaries of a social security scheme.
Non inclusion criteria :
Patients
- Patient with a contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical cardiac valve, old vascular clips on cerebral aneurysm, etc.
- Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion.
Controls :
- Patient with a contraindication to MRI: ocular metallic foreign body, pacemaker, cardiac mechanical valve, old vascular clips on cerebral aneurysm, etc.
- Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site
Necker enfants malades Hospital
Paris, Île-de-France Region, 75015
About this study
This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech.
To make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific patient and its pathological variations. Patient-specific 3D reconstruction provides a significant improvement, leading to a precise assessment of the malformation or tumour and its relationship with surrounding organs, nerves and vessels. It allows the surgeon to simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction technology.
The study aims to provide an aid to diagnosis and surgical planning by developing dedicated methods and algorithms for segmenting not only the tumour but also the main anatomical components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired on a routine clinical basis with an expected benefit for patients.
- Conditions
- Malformation, Tumor, Paediatric Surgery, 3D Imaging
- Medical subject headings
- Congenital Abnormalities, Neoplasms
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 |
|---|---|---|
| Malformation | Not described | |
| Tumors | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images produced by General Electrics' 3 Tesla MRI
Nerve network in areas of interest (pelvis) using tractography analysis with 3 Tesla MRI by automation of 3D imaging using images produced by General Electrics' 3 Tesla MRI. This automation will be carried out using software developed by Telecom Paristech.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Post-operative consequences of surgery and/or rehabilitation treatment in patients with abdomino-pelvic tumours or pelvic malformations.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start16 Apr 2016
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalformationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224985
- Sponsor's protocol ID
- IMAG 2
- Acronym
- IMAG2
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Anatomy in Surgery for Childhood Tumours and Malformations
- ClinicalTrials.gov ID
- NCT06224985
- Acronym / sponsor ID
- IMAG2 / IMAG 2
- Conditions
- Malformation, Tumor, Paediatric Surgery, 3D Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 25 Jan 2024 (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.
This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech.
To make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific patient and its pathological variations. Patient-specific 3D reconstruction provides a significant improvement, leading to a precise assessment of the malformation or tumour and its relationship with surrounding organs, nerves and vessels. It allows the surgeon to simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction technology.
The study aims to provide an aid to diagnosis and surgical planning by developing dedicated methods and algorithms for segmenting not only the tumour but also the main anatomical components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired on a routine clinical basis with an expected benefit for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malformation | – | – |
| Tumors | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 5 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients included in the three groups are followed in the visceral surgery department of Necker-Enfants Malades Hospital in Paris (France) for whose an MRI is required as part of diagnosis, extension assessment or monitoring.
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
Images produced by General Electrics' 3 Tesla MRI
Time frame: through study completion, an average of 1 year
Nerve network in areas of interest (pelvis) using tractography analysis with 3 Tesla MRI by automation of 3D imaging using images produced by General Electrics' 3 Tesla MRI. This automation will be carried out using software developed by Telecom Paristech.
1 secondary outcome
Post-operative consequences of surgery and/or rehabilitation treatment in patients with abdomino-pelvic tumours or pelvic malformations.
Time frame: through study completion, an average of 1 year
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 30 Jan 2024.
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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.
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?
An observational study of Malformation and Tumor, run by Imagine Institute 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?
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 30 Jan 2024. 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?
Images produced by General Electrics' 3 Tesla MRI (time frame: through study completion, an average of 1 year). 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 30 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.