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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ketorres@mdanderson.org
• Phone: (713) 792-4242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.