DoD Award NF230020 Identification of Metabolic Markers and Statistical Prediction of MPNST for Rapid Diagnosis and Assessment of Surgical Margins

September 17, 2026 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Keila Torres, MD,PHD
Phone Number: (713) 792-4242
Email: ketorres@mdanderson.org

Study Locations

United States
- Texas
  - Houston, Texas, United States, 77090
    - Recruiting
    - The University of Texas M. D. Anderson Cancer Center
    - Contact:
      
      Keila Torres, MD,PHD
      
      Phone Number: 713-792-4242
      
      Email: ketorres@mdanderson.org
    - Principal Investigator:
      
      Keila Torres, MD,PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

For Aim 1: 100 neurofibromas and 104 MPNST snap-frozen, clinically and pathologically annotated samples have been identified. These have been collected under protocol LAB06-0851.

For Aim 2: We will evaluate the technology in the OR and enable surgeons to collect molecular data from a cohort of 60 patients undergoing resection of suspected or diagnosis of MPNST/neurofibroma (protocol: 2019-1118).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Adverse Events (AEs) Time Frame: Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Keila Torres, MD,PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

askmdanderson@mdanderson.org

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 20, 2032

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria