Clinical trial · Interventional
Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1
Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 and High Plexiform Neurofibroma Tumor Burden
NCT03820778CI-TRIAL-00050391active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Neurofibroma | Atypical Neurofibromatous Neoplasm of Uncertain Biologic Potential | ALIAS | 0.90 |
| Atypical Neurofibromatosis | — | UNRESOLVED | — |
| Neurofibroma | Neurofibroma | ONTOLOGY_EXACT | 0.98 |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
| Plexiform Neurofibroma | Plexiform Neurofibroma | ONTOLOGY_EXACT | 0.98 |
| Von Recklinghausen Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Whole Body MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- 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.
- interventionNames
- Diagnostic Test: Whole Body MRI
Primary outcomes (1)
- measure
- To determine if WBMRI can be used to identify ANF in NF1 patients with high tumor burden.
- timeFrame
- 2-3 years
- description
- Number of NF1 participants with high tumor burden who have ANF on WBMRI
Secondary outcomes (1)
- measure
- Determine if clinical signs and symptoms correlate with tumor burden and/or the presence of ANF on WBMRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDNguyen R, Dombi E, Widemann BC, Solomon J, Fuensterer C, Kluwe L, Friedman JM, Mautner VF. Growth dynamics of plexiform neurofibromas: a retrospective cohort study of 201 patients with neurofibromatosis 1. Orphanet J Rare Dis. 2012 Oct 4;7:75. doi: 10.1186/1750-1172-7-75. PMID 23035791
- BACKGROUNDKim A, Stewart DR, Reilly KM, Viskochil D, Miettinen MM, Widemann BC. Malignant Peripheral Nerve Sheath Tumors State of the Science: Leveraging Clinical and Biological Insights into Effective Therapies. Sarcoma. 2017;2017:7429697. doi: 10.1155/2017/7429697. Epub 2017 May 16. PMID 28592921
- BACKGROUNDHigham CS, Dombi E, Rogiers A, Bhaumik S, Pans S, Connor SEJ, Miettinen M, Sciot R, Tirabosco R, Brems H, Baldwin A, Legius E, Widemann BC, Ferner RE. The characteristics of 76 atypical neurofibromas as precursors to neurofibromatosis 1 associated malignant peripheral nerve sheath tumors. Neuro Oncol. 2018 May 18;20(6):818-825. doi: 10.1093/neuonc/noy013. PMID 29409029
- BACKGROUNDBeert E, Brems H, Daniels B, De Wever I, Van Calenbergh F, Schoenaers J, Debiec-Rychter M, Gevaert O, De Raedt T, Van Den Bruel A, de Ravel T, Cichowski K, Kluwe L, Mautner V, Sciot R, Legius E. Atypical neurofibromas in neurofibromatosis type 1 are premalignant tumors. Genes Chromosomes Cancer. 2011 Dec;50(12):1021-32. doi: 10.1002/gcc.20921. Epub 2011 Aug 24. PMID 21987445
- BACKGROUNDMautner VF, Asuagbor FA, Dombi E, Funsterer C, Kluwe L, Wenzel R, Widemann BC, Friedman JM. Assessment of benign tumor burden by whole-body MRI in patients with neurofibromatosis 1. Neuro Oncol. 2008 Aug;10(4):593-8. doi: 10.1215/15228517-2008-011. Epub 2008 Jun 17. PMID 18559970
- BACKGROUNDDominguez-Vigil IG, Moreno-Martinez AK, Wang JY, Roehrl MHA, Barrera-Saldana HA. The dawn of the liquid biopsy in the fight against cancer. Oncotarget. 2017 Dec 8;9(2):2912-2922. doi: 10.18632/oncotarget.23131. eCollection 2018 Jan 5.