Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1
- Many people with neurofibromatosis type 1 (NF1) get tumors of the nervous system. Finding malignant tumors early is important for removing them. Researchers want to find ways of doing this with scans and genetic testing.
- To learn more about neurofibromatosis type 1.
- People age 10 and older with NF1 who have a benign tumor or have had a malignant one.
- Participants will be screened in another study with medical history, physical exam, and urine and blood tests. They will have a magnetic resonance imaging (MRI) scan.
- MRI: Participants will lie on a table that slides into a metal cylinder. They will be in the scanner for 60 90 minutes, lying still for 15 minutes at a time. Participants will get earplugs for the loud sounds. They will get a contrast agent (dye) through a thin plastic tube (catheter) inserted in an arm vein.
- As part of their regular care, participants will have:
- FDG-PET/CT scan. They will get radioactive glucose (sugar) through a catheter in an arm vein.
- [18F]-FLT-PET/CT scan. This is like the FDG scan but with a different radioactive chemical.
- Biopsy. A piece of tumor tissue is removed with a needle. A piece of tissue from a previous biopsy may also be studied.
- Participants may have genetic testing. Blood will be taken. It will be tested along with biopsy samples. Researchers will explain the risks and procedures. They may notify participants if testing shows health problems.
- After this study, participants will continue their regular cancer care.
|Neurofibromatosis MPNST||Procedure: MRI, FDG-PET/CT scans Procedure: [18F]-FLT-PET/CT scans||Early Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1: Clinical, Histopathologic, and Genomic Analysis|
- Feasibility [ Time Frame: 3 years ]
- Ability to distinguish lesions and accuracy [ Time Frame: 3 years ]
- Feasibility of whole-exome sequencing [ Time Frame: 3 years ]
- Clinical analysis for NF1/MPNST [ Time Frame: 3 years ]
- Pathological analysis [ Time Frame: 3 years ]
- Identify somatic genetic variants [ Time Frame: 3 years ]
|Study Start Date:||August 1, 2014|
|Estimated Study Completion Date:||July 1, 2018|
|Estimated Primary Completion Date:||July 1, 2018 (Final data collection date for primary outcome measure)|
FDG & FLT PET followed by potential biopsies and exome sequencing
Procedure: MRI, FDG-PET/CT scans
Per standard of careProcedure: [18F]-FLT-PET/CT scans
Per research study
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02211768
|Contact: Anne Goodwin, R.N.||(301) email@example.com|
|Contact: Brigitte C Widemann, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Brigitte C Widemann, M.D.||National Cancer Institute (NCI)|