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

NCT07298083 | Recruiting

• 2 other identifiers: 2025-0371NCI-2025-09278
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromas; MPNST

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  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.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77090, United States

RECRUITING

Related Links

• askmdanderson@mdanderson.org

MeSH Terms

Conditions

Neurofibroma; Neurofibrosarcoma

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Study Officials

• Keila Torres, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keila Torres, MD,PHD

CONTACT

(713) 792-4242; ketorres@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 23, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 20, 2032
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)