Actively Recruiting

Age: 1Year +
All Genders
ID07298083

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

Led by M.D. Anderson Cancer Center · Updated on 2026-04-09

60

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to learn if a handheld Mass Spectrometry device called the MasSpec Pen can accurately identify malignant peripheral nerve sheath tumors (MPNST), neurofibroma, and normal nerve tissue during surgery. The study focuses on finding specific metabolic markers and validating the device's ability to help diagnose these conditions and assess surgical margins in real time. Participants with diagnosed MPNST or neurofibroma who are scheduled for surgical removal of these tumors as part of their usual care will be included. The study will analyze the metabolite and lipid profiles of the tumor and nerve tissues and test the handheld mass spectrometry device during surgery to evaluate its diagnostic accuracy and use in guiding surgical decisions. During the study, participants will undergo standard surgical procedures while researchers collect data using the device. Safety and any adverse events will be monitored throughout the study, which is expected to last about one year per participant. This observational study includes patients aged 1 year and older and will track how well the device performs in distinguishing tumor tissue during surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with either malignant peripheral nerve sheath tumor (MPNST) or neurofibroma and scheduled for surgical removal as part of standard care
  • Age 1 year or older; participants younger than 18 require consent from both parents
  • Have at least one measurable lesion of 10 mm (1 cm) or larger by CT scan, MRI, or clinical exam
  • Include both recurrent and primary disease cases
  • Adults over 18 must understand and be willing to sign informed consent
  • Open to English and non-English speaking patients
Not Eligible

You will not qualify if you...

  • Adults with cognitive impairments needing a legally authorized representative for consent
  • Patients under 1 year old and newborns
  • Pregnant patients undergoing surgery for MPNST

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to surgery date

Participants undergo metabolic profiling and diagnostic assessments using the handheld mass spectrometry device for tumor identification and surgical margin evaluation.

1 to 2 visits depending on surgical scheduling

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants have surgical removal of the tumor as part of standard care with intraoperative evaluation using the mass spectrometry device.

1 surgical visit and immediate post-operative monitoring

Long-term Monitoring

Duration - Approximately 1 year

Participants are monitored for safety and adverse events for about one year after surgery.

Periodic follow-up visits during the monitoring period

Trial Site Locations

Total: 1 location

1

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77090

Actively Recruiting

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Research Team

K

Keila Torres, MD,PHD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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