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

M.D. Anderson Cancer Center

Status: Begins enrollment in 1 month

Conditions: Neurofibromas; MPNST

Study type: Observational

Funder types: Other

Identifiers

NCT07298083

NCI-2025-09278 (Other Identifier)

2025-0371

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
3. 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.
4. Recurrent or primary disease.
5. Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
6. English and non-English speaking patients.

Exclusion criteria

1. Adult patients with cognitive impairment requiring a legally authorized representative for consent.
2. Patients under age 1 and neonates.
3. Patients who are pregnant and undergoing surgery for MPNST are not eligible.