Whole Body ImagingNEFIMARNCT01777451
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis
An observational study of Whole Body Imaging and Magnetic Resonance Imaging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Whole body MRI will be performed in patients with neurofibromatosis Type 1 PURPOSE 1: To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Whole Body Imaging, Magnetic Resonance Imaging, Neurofibromatosis 1
- What is being tested?
- Additional imaging or surgery
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2010to Jan 2014
- 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 6 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients with a clinically proven neurofibromatosis type 1 can be included.
Who may be able to join
- Patients with neurofibromatosis type 1, between 6 and 50 years old
Who cannot join
- Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven
Steven Pans, MD, 3216340505, steven.pans@uzleuven.be
About this study
Whole body MRI will be performed in patients with neurofibromatosis Type 1
PURPOSE 1:
To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.
PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas
PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.
PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings
- Conditions
- Whole Body Imaging, Magnetic Resonance Imaging, Neurofibromatosis 1, Diffusion Magnetic Resonance Imaging, Peripheral Nerve Sheath Tumors, Malignant
- Being tested
- Additional imaging or surgery
- Keywords
- Whole Body Imaging, Magnetic Resonance Imaging, Neurofibromatosis 1, Diffusion Magnetic Resonance Imaging, Peripheral Nerve Sheath Tumors, Malignant
- Medical subject headings
- Neurofibromatosis 1, Neurofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional imaging or surgeryOther
No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)
| Study group | Role | What they receive |
|---|---|---|
| Neurofibromatosis 1 | All patients diagnosed with neurofibromatosis type 1. GROUP 1:ADDITIONAL IMAGING OR SURGERY There will be patients with high-risk neurofibromas (potential malignant). These patients will underwent additional examinations or surgery (outside this study). Follow-up MRI within 2 years (study MRI )
GROUP 2:
No suspicious lesions at MRI. Follow-up within 2 years(Study MRI). Receives: Other: Additional imaging or surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of total tumor load and diagnosis of high-risk neurofibromas
Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence.
Measured: 1 month
Secondary outcomes (1)
To diagnose high-risk neurofibroma
Some patients with neurofibromatosis have lesions, pre-malignant or malignant neurofibromas. Additional imaging (PET-CT), a biopsy or surgical treatment is necessary in combination with histopathology of the lesion.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startDec 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Whole Body ImagingStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Pans, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Steven Pans, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777451
- Sponsor's protocol ID
- NEFIMAR
- Other IDs
- S52684
- Acronym
- NEFIMAR
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tucker T, Friedman JM, Friedrich RE, Wenzel R, Funsterer C, Mautner VF. Longitudinal study of neurofibromatosis 1 associated plexiform neurofibromas. J Med Genet. 2009 Feb;46(2):81-5. doi: 10.1136/jmg.2008.061051. Epub 2008 Oct 17.
PubMed 18930997Cai W, Kassarjian A, Bredella MA, Harris GJ, Yoshida H, Mautner VF, Wenzel R, Plotkin SR. Tumor burden in patients with neurofibromatosis types 1 and 2 and schwannomatosis: determination on whole-body MR images. Radiology. 2009 Mar;250(3):665-73. doi: 10.1148/radiol.2503080700.
PubMed 19244040Van Meerbeeck SF, Verstraete KL, Janssens S, Mortier G. Whole body MR imaging in neurofibromatosis type 1. Eur J Radiol. 2009 Feb;69(2):236-42. doi: 10.1016/j.ejrad.2008.10.024. Epub 2008 Dec 16.
PubMed 19091504
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis
- ClinicalTrials.gov ID
- NCT01777451
- Acronym / sponsor ID
- NEFIMAR / NEFIMAR
- Conditions
- Whole Body Imaging, Magnetic Resonance Imaging, Neurofibromatosis 1, Diffusion Magnetic Resonance Imaging, Peripheral Nerve Sheath Tumors, Malignant
- Keywords
- Whole Body Imaging, Magnetic Resonance Imaging, Neurofibromatosis 1, Diffusion Magnetic Resonance Imaging, Peripheral Nerve Sheath Tumors, Malignant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 28 Jan 2013 (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.
Whole body MRI will be performed in patients with neurofibromatosis Type 1
PURPOSE 1:
To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.
PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas
PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.
PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofibromatosis 1 | – | Other: Additional imaging or surgeryAll patients diagnosed with neurofibromatosis type 1. GROUP 1:ADDITIONAL IMAGING OR SURGERY There will be patients with high-risk neurofibromas (potential malignant). These patients will underwent additional examinations or surgery (outside this study). Follow-up MRI within 2 years (study MRI ) GROUP 2: No suspicious lesions at MRI. Follow-up within 2 years(Study MRI). |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients with a clinically proven neurofibromatosis type 1 can be included.
Key inclusion criteria (1 listed)
- Patients with neurofibromatosis type 1, between 6 and 50 years old
Key exclusion criteria (1 listed)
- Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)
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 |
|---|---|---|
| Additional imaging or surgeryNo specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy) | Other | Neurofibromatosis 1 |
Primary outcome
Estimation of total tumor load and diagnosis of high-risk neurofibromas
Time frame: 1 month
Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence.
1 secondary outcome
To diagnose high-risk neurofibroma
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
- Background: PubMed 18930997Tucker T, Friedman JM, Friedrich RE, Wenzel R, Funsterer C, Mautner VF. Longitudinal study of neurofibromatosis 1 associated plexiform neurofibromas. J Med Genet. 2009 Feb;46(2):81-5. doi: 10.1136/jmg.2008.061051. Epub 2008 Oct 17.
- Background: PubMed 19244040Cai W, Kassarjian A, Bredella MA, Harris GJ, Yoshida H, Mautner VF, Wenzel R, Plotkin SR. Tumor burden in patients with neurofibromatosis types 1 and 2 and schwannomatosis: determination on whole-body MR images. Radiology. 2009 Mar;250(3):665-73. doi: 10.1148/radiol.2503080700.
- Background: PubMed 19091504Van Meerbeeck SF, Verstraete KL, Janssens S, Mortier G. Whole body MR imaging in neurofibromatosis type 1. Eur J Radiol. 2009 Feb;69(2):236-42. doi: 10.1016/j.ejrad.2008.10.024. Epub 2008 Dec 16.
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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.
Steven Pans, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Whole Body Imaging and Magnetic Resonance Imaging, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2013. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Pans, MD (3216340505s, steven.pans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of total tumor load and diagnosis of high-risk neurofibromas (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777451, which also lists 3 linked publications.
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 28 Jan 2013.