MedTrace Logo

Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1

NCT02211768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

  • Neurofibromatosis
  • MPNST

Interventions

PROCEDURE

MRI, FDG-PET/CT scans

Standard of care to be obtained as part of the study

DRUG

[18F]-FLT-PET/CT scans

FLT PET to be performed as a research imaging study as it is not considered standard imaging in NF1

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brigitte C Widemann, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-09-05
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02211768 on ClinicalTrials.gov