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Pen-Like device could help surgeons detect cancer in real time

NCT ID NCT07298083

Diagnosis Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests whether a handheld device called the MasSpec Pen can tell the difference between cancerous MPNST, benign neurofibromas, and normal tissue during surgery. About 60 people with MPNST or neurofibroma will take part. The goal is to see if the device is safe and accurate enough to help surgeons remove all cancer in one operation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MasSpec Pen (handheld mass spectrometry device)
What this could lead to
If successful, this could give surgeons a real-time tool to identify cancerous tissue during surgery, potentially improving tumor removal and reducing repeat surgeries.
What could go wrong
This is a small, early-stage study (60 participants) focused on feasibility and safety. The device may not prove accurate enough in larger, more diverse groups, and technical issues could arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

malignant peripheral nerve sheath tumor neurofibroma neurofibrosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MPNST Neurofibromas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The University of Texas M. D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77090, United States

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