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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07298083

Enrollment

Registered

2025-12-23

Start date

2026-04-02

Completion date

2032-04-20

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MPNST, Neurofibromas

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and Adverse Events (AEs)	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

Countries

United States

Contacts

CONTACTKeila Torres, MD,PHD

ketorres@mdanderson.org(713) 792-4242

PRINCIPAL_INVESTIGATORKeila Torres, MD,PHD

M.D. Anderson Cancer Center

Outcome results