Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1
Completed · Phase 1
Conditions studied: Neurofibromatosis, MPNST
In brief
Background:\<TAB\> \- 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. Objectives: \- To learn more about neurofibromatosis type 1. Eligibility: \- People age 10 and older with NF1 who have a benign tumor or have had a malignant one. Design: * 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.
Key facts
- Study ID
- NCT02211768
- Run by
- National Cancer Institute (NCI)
- People needed
- 10
- Starts
- 2014-12-08
- Expected to finish
- 2019-12-30
- Last updated by the study team
- 2026-08-04
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Allergy or relative contraindications to MRI contrast agents.
- Patients who require sedation for imaging studies will be excluded from the FLT PET scan research test. They will undergo only the standard of care MRI and FDG PET scan.
- Contraindication to MRI scanning, such as surgery that involves metal clips or wires or metal prostheses which might be expected to cause tissue damage or produce image artifacts.
- Patients with severe chronic renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m(2)), hepatorenal syndrome or post-liver transplantation.
- History of prior fluorothymidine allergy or intolerance.
- Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing >136 kg (weight limit for scanner table)
- Pregnant women are excluded from this study because of the effects of radioactive materials with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radioactive materials, breastfeeding should be discontinued.
- Requirement for medications, which interfere with platelet function, such as aspirin, which cannot be stopped within 1 week prior to the biopsy (applicable only to patients undergoing biopsy).
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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