An interventional study of Whole Body MRI in Neurofibromatosis 1, Neurofibroma and Atypical Neurofibroma, sponsored by Children's National Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years to 30 Years. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Diagnostic
This study is being conducted to determine if Whole Body MRI (WBMRI) can be used to identify Atypical Neurofibromas (ANF) in Neurofibromatosis Type 1 (NF1) patients with high tumor burden. Each enrolled participant will have two (2) WBMRIs without sedation during the study period. Eligible participants must be Male or Female between the ages of 8-30 with diagnosed NF1; with one or more PN greater than 3cm in diameter and willing to comply with study procedures.
This is a study to determine the feasibility of using Whole Body MRI (WBMRI) to detect Atypical Plexiform Neurofibromas (ANF) among Neurofibromatosis Type 1 (NF1) patients who are at highest risk for developing these tumors. In order to do this, the investigators will prospectively obtain WBMRI scans on patients with high plexiform tumor burden (which investigators will define as >=1 plexiform neurofibroma (PN) that is >3cm in diameter on MRI) at the same time as their regularly scheduled MRI to allow for radiographic comparison of the identified PNs. In this study, the investigators will plan to establish a method that effectively characterizes PNs in terms of their volume, radiographic appearance on WBMRI and association with clinical characteristics.
As an exploratory aim, the investigators plan to collect blood samples from each patient at the same time as the MRI to determine the feasibility of isolating cfDNA (circulating free DNA) from plasma of patients with high plexiform tumor burden.
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's enrollment of 10 is below the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Whole Body MRI along with standard of care regional MRI and blood draw at enrollment followed by Whole Body MRI along with standard of care regional MRI and blood draw after 4-6 months.
Diagnostic Test: Whole Body MRI
WBMRI with axial and coronal STIR (short inversion time inversion recovery) images + DWI (diffuse weighted imaging) will be performed and compared to regional MRI to assess value of this diagnostic test for the identification of suspicious looking lesions (i.e. diffuse nodular lesions or atypical plexiform neurofibroma)
To determine if WBMRI can be used to identify ANF in NF1 patients with high tumor burden.
Number of NF1 participants with high tumor burden who have ANF on WBMRI
Time frame: 2-3 years
Determine if clinical signs and symptoms correlate with tumor burden and/or the presence of ANF on WBMRI
Number of patients with high PN tumor burden who have clinical symptoms
Time frame: 2-3 years
Determine if the cfDNA levels correlate with presence of ANF.
Level of cfDNA in plasma of participants with ANF compared to participants without ANF
Time frame: 3-4 years
Plan to share: No
This study is active, not recruiting, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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