Handheld mass spectrometry to tell MPNST, neurofibroma, and normal nerve tissue during surgery

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

This study will test whether a handheld mass spectrometry device can quickly tell malignant peripheral nerve sheath tumors (MPNST) from neurofibromas and normal nerve tissue during surgery for patients having tumor removal.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07298083 on ClinicalTrials.gov

What this trial studies

This observational study will collect tissue and metabolic data from about 60 patients with MPNST or neurofibroma who are undergoing surgical resection at M.D. Anderson. Researchers will map metabolite and lipid profiles of tumor, neurofibroma, and nerve tissue and build statistical models to distinguish them. The handheld MasSpec Pen combined with an Orbitrap mass spectrometer will be used intraoperatively to sample tissues and compare its readings to pathology and the metabolomic profiles. The goal is to validate the device for rapid intraoperative diagnosis and to help define surgical margins.

Who should consider this trial

Good fit: Patients aged 1 year and older with a measurable MPNST or neurofibroma who are scheduled for surgical resection and can provide consent (or have parental consent) are ideal candidates.

Not a fit: Patients who are pregnant, younger than one year, unable to undergo surgery, or unable to provide consent are unlikely to benefit from this intraoperative validation.

Why it matters

Potential benefit: If successful, surgeons could more quickly distinguish MPNST from benign neurofibromas and better define surgical margins, potentially reducing repeat operations and preserving healthy nerve tissue.

How similar studies have performed: Handheld mass spectrometry tools like the MasSpec Pen have shown promising tumor-versus-normal discrimination in other cancer types, but their use specifically for MPNST and neurofibroma margin assessment is novel.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Keila Torres, MD,PHD — M.D. Anderson Cancer Center
• Study coordinator: Keila Torres, MD,PHD

Conditions Neurofibromas; MPNST