Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofib… (NCT02211768) | Clinical Trial Compass
CompletedPhase 1
Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1
United States10 participantsStarted 2014-12-08
Plain-language summary
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.
Who can participate
Age range10 Years
SexALL
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Inclusion criteria
✓. Six or more caf(SqrRoot)(Copyright)-au-lait spots (greater than or equal to 0.5 cm in prepubertal subjects or greater than or equal to 1.5 cm in postpubertal subjects)
✓. Greater than or equal to 2 neurofibromas or 1 plexiform neurofibroma
✓. Freckling in the axilla or groin
✓. Optic glioma
✓. Two or more Lisch nodules
✓. A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)
✓. A first-degree relative with NF1
✓. Diagnosis of NF1 with a lesion concerning for MPNST
Exclusion criteria
✕. 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.
What they're measuring
1
Evaluate the feasibility of whole-exome sequencing and other genetic/genomic methods
Timeframe: 3 years
2
Evaluate the ability of FLT PET to distinguish benign PN from malignant lesions, and to determine if FLT PET is more accurate than FDG PET in classifying a tumor as benign or malignant
Timeframe: 3 years
3
Determine the feasibility of FLT PET in patients with NF1 and lesions concerning for MPNST, or MPNST
✕. 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).