DoD Award NF230020 Identification of Metabolic Markers and Statistical Prediction of MPNST for Rapid Diagnosis and Assessment of Surgical Margins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurofibromas, MPNST. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The goal of this clinical research study is to learn if a handheld Mass Spectrometry device (MasSpec Pen) can accurately distinguish between masses, neurofibroma, and normal tissue during surgery.
Detailed description
Primary Objectives:
Aim 1. Determine the metabolite and lipid profiles of MPNST, neurofibroma, and nerve tissues
Aim 2. Validate the handheld mass spectrometry device (MSPen-Orbitrap system) for MPNST and neurofibroma diagnosis and for intraoperative surgical margin evaluation
Primary outcome measures
- Safety and Adverse Events (AEs) [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
Inclusion criteria
- This study will enroll approximately 60 participants diagnosed with either MPNST or neurofibroma who are undergoing surgical resection of an MPNST or neurofibroma as part of their standard of care.
- Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- Recurrent or primary disease.
- Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
- English and non-English speaking patients.
Exclusion criteria
- Adult patients with cognitive impairment requiring a legally authorized representative for consent.
- Patients under age 1 and neonates.
- Patients who are pregnant and undergoing surgery for MPNST are not eligible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University of Texas M. D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT07298083 · 2025-0371 · NCI-2025-09278