NeurofibromasNCT07298083
DoD Award NF230020 Identification of Metabolic Markers and Statistical Prediction of MPNST for Rapid Diagnosis and Assessment of Surgical Margins
An observational study of Neurofibromas and MPNST, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Neurofibromas, MPNST
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to 20 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
- Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
- 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.
- Recurrent or primary disease.
- Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
- English and non-English speaking patients.
Who cannot join
- Adult patients with cognitive impairment requiring a legally authorized representative for consent.
- Patients under age 1 and neonates.
- Patients who are pregnant and undergoing surgery for MPNST are not eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77090
Keila Torres, MD,PHD, 713-792-4242, ketorres@mdanderson.org
Keila Torres, MD,PHD
About this study
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.
Read the detailed description
Primary Objectives:
Aim 1. Determine the metabolite and lipid profiles of MPNST, neurofibroma, and nerve tissues
Aim 2. Validate the handheld mass spectrometry device (MSPen-Orbitrap system) for MPNST and neurofibroma diagnosis and for intraoperative surgical margin evaluation
- Conditions
- Neurofibromas, MPNST
- Medical subject headings
- Neurofibroma, Neurofibrosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start2 Apr 2026
- Primary completion30 Apr 2030 (estimated)
- Study completion20 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromasStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keila Torres, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298083
- Sponsor's protocol ID
- 2025-0371
- Other IDs
- NCI-2025-09278
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DoD Award NF230020 Identification of Metabolic Markers and Statistical Prediction of MPNST for Rapid Diagnosis and Assessment of Surgical Margins
- ClinicalTrials.gov ID
- NCT07298083
- Acronym / sponsor ID
- 2025-0371
- Conditions
- Neurofibromas, MPNST
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 20 Apr 2032 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
Aim 1. Determine the metabolite and lipid profiles of MPNST, neurofibroma, and nerve tissues
Aim 2. Validate the handheld mass spectrometry device (MSPen-Orbitrap system) for MPNST and neurofibroma diagnosis and for intraoperative surgical margin evaluation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (6 listed)
- 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.
- Age ≥ 1 years. Individuals younger than 18 years old will be included. For patients of age < 18 years, both parents' signatures will be requested.
- 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.
- Recurrent or primary disease.
- Patients who are > 18 years should have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Adult patients with cognitive impairment requiring a legally authorized representative for consent.
- Patients under age 1 and neonates.
- Patients who are pregnant and undergoing surgery for MPNST are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- askmdanderson@mdanderson.orgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keila Torres, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromas and MPNST, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keila Torres, MD,PHD ((713) 792-4242, ketorres@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.