Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 8 - 30 |
| Updated: | 1/31/2019 |
| Start Date: | July 12, 2018 |
| End Date: | July 12, 2022 |
Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 and High Plexiform Neurofibroma Tumor Burden
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.
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.
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.
Inclusion Criteria:
1. Males or females between 8-30 years of age
2. Confirmed diagnosis of NF1
3. Stated willingness to comply with all study procedures and availability for the
duration of the study
4. Prior MRI documentation confirming >=1 PN that is >3cm in diameter
Exclusion Criteria:
1. Unable to undergo MRI without sedation
2. Presence of metal or other devices that are contraindicated for MRI
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