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NCT02211768 · ClinicalTrials.gov registry record · Phase 1
Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1
A Phase 1 study of Neurofibromatosis and MPNST, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02211768: Completed Phase 1 study of Neurofibromatosis and MPNST, sponsored by National Cancer Institute (NCI).
NCT02211768 is a Phase 1 study of Neurofibromatosis and MPNST that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 127-participant average among 5 other Neurofibromatosis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02211768, a Phase 1 study of Neurofibromatosis and MPNST, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Genomic profile of subject's tumors to catalogue mutations associated with the development of a PN and then a MPNST
Conditions Studied
Interventions
- PROCEDURE MRI, FDG-PET/CT scans
- DRUG [18F]-FLT-PET/CT scans
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-12-08 |
| Est. Completion | 2019-12-30 |
| Phase | Phase 1 |
What the finished NCT02211768 record still lists
NCT02211768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 127-participant average among 5 other Neurofibromatosis trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Neurofibromatosis appearing as the primary indexed condition, and to 2 interventions - of which MRI, FDG-PET/CT scans is the first listed.
NCT02211768 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02211768 about?
NCT02211768 is a clinical study titled "Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1". 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 t...
What is the current status of trial NCT02211768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-12-08. Estimated completion is 2019-12-30.
What conditions does trial NCT02211768 study?
This clinical trial studies the following conditions: Neurofibromatosis, MPNST.
What interventions are being tested in trial NCT02211768?
The interventions under investigation include: MRI, FDG-PET/CT scans (PROCEDURE), [18F]-FLT-PET/CT scans (DRUG).
Who is sponsoring clinical trial NCT02211768?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02211768 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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