Recruiting

MasSpec Pen

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07298083

Conditions

Neurofibromas

MPNST

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07298083

Start date

Apr 2, 2026

Status verified date

Apr, 2026

Completion date

Apr 20, 2032

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77090

Contacts

Principal Investigator:

Keila Torres, MD,PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-09.