Central Nervous System NeoplasmNCT04539574
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
A study testing 7 Tesla Magnetic Resonance Imaging and Questionnaire Administration in people with Central Nervous System Neoplasm and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System
- What is being tested?
- 7 Tesla Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2020to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients must meet one set of inclusion criteria:
- Newly identified and untreated central nervous system glioma or metastasis of at least 5 mm or greater in size
- Suspected central nervous system neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon or a radiation oncology that a lesion exists that is most likely either a glioma or a metastasis
- Patients with suspected brain metastasis must also have a history of solid organ malignancy
- History of central nervous system glioma or metastasis treated with surgery, radiation, chemotherapy, or immunotherapy with new or increasing signal on MR imaging that is suspicious for progressive disease (treatment failure)
- Suspected recurrent neoplasms will require agreement from a study neuroradiologist and a study neurosurgeon, radiation oncologist, or neuro-oncologist that lesion behavior is suspicious for recurrent disease
Who cannot join
- Contraindication to MR imaging
- Absolute or relative contra-indication to 3T MRI due to metallic foreign bodies and devices and/or other conditions that are not MR safe, which include implants with unknown behavior in 3T MRI as well as:
- Electronically, magnetically, and mechanically activated implants
- Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
- Metallic splinters in the eye
- Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
Show all 18Show fewer
- Cochlear implants
- Other pacemakers, e.g., for the carotid sinus
- Insulin pumps and nerve stimulators
- Non-MR safe lead wires
- Prosthetic heart valves (if dehiscence is suspected)
- Non-ferromagnetic stapedial implants
- Pregnancy
- Claustrophobia that does not readily respond to oral medication
- Known allergy to gadolinium-based contrast agents
- Renal failure as defined by a glomerular filtration rate (GFR) less than 30 or the use of hemodialysis
- Pregnant
- Interval treatment with radiation or surgery between the diagnostic MRI lesion identification and planned study MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy
This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.
SECONDARY OBJECTIVE:
- To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.
EXPLORATORY OBJECTIVES:
- To assess patient experience in the 7 Tesla (7T) magnetic resonance imaging (MRI) system compared to their most recent MRI examination.
II. To assess the typical significance values seen for areas of maximal brain activity associated with each functional MRI (fMRI) test.
III. To assess the geometric distortion of a radiation planning sequence on a ultra-high field (UHF) system.
OUTLINE:
Patients undergo 7T MRI over 60 minutes.
- Conditions
- Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Malignant Solid Neoplasm
- Being tested
- 7 Tesla Magnetic Resonance Imaging, Questionnaire Administration
- Medical subject headings
- Central Nervous System Neoplasms, Glioma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 7 Tesla MRI, 7T MRI
Undergo 7T MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (7T MRI) | Experimental | Patients undergo 7T MRI over 60 minutes. Receives: Procedure: 7 Tesla Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-to-noise Ratio (CNR)
Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start4 Sep 2020
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Nervous System NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Max Wintermark, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539574
- Sponsor's protocol ID
- 2019-1032
- Other IDs
- NCI-2020-06374, 2019-1032
- Status last verified
- Dec 2024
- First submitted
- 31 Aug 2020
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Multi-Parametric Ultra-High Field MRI Protocol for Central Nervous System Malignancy
- ClinicalTrials.gov ID
- NCT04539574
- Acronym / sponsor ID
- 2019-1032
- Conditions
- Central Nervous System Neoplasm, Glioma, Metastatic Malignant Neoplasm in the Central Nervous System, Metastatic Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial investigates how well 7T MRI scan works in imaging central nervous system tumors. Diagnostic procedures, such as 7T MRI, may help find and diagnose central nervous system tumors and help measure a patient's response to earlier treatment. The goal of this trial is to learn if a new MRI system can provide better quality images than a standard MRI.
Detailed description
PRIMARY OBJECTIVE:
- To estimate the contrast-to-noise ratio (CNR) for several imaging modalities in brain malignancy as compared with normal brain parenchyma separately by type of malignancy and treatment status.
SECONDARY OBJECTIVE:
- To assess the conspicuity of each imaging modality to differentiate radiation necrosis from progressive disease.
EXPLORATORY OBJECTIVES:
- To assess patient experience in the 7 Tesla (7T) magnetic resonance imaging (MRI) system compared to their most recent MRI examination.
II. To assess the typical significance values seen for areas of maximal brain activity associated with each functional MRI (fMRI) test.
III. To assess the geometric distortion of a radiation planning sequence on a ultra-high field (UHF) system.
OUTLINE:
Patients undergo 7T MRI over 60 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (7T MRI) | Experimental | Procedure: 7 Tesla Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients undergo 7T MRI over 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients must meet one set of inclusion criteria:
Key exclusion criteria (18 listed)
- Contraindication to MR imaging
- Absolute or relative contra-indication to 3T MRI due to metallic foreign bodies and devices and/or other conditions that are not MR safe, which include implants with unknown behavior in 3T MRI as well as:
- Pregnancy
- Claustrophobia that does not readily respond to oral medication
- Known allergy to gadolinium-based contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 Tesla Magnetic Resonance ImagingAlso: 7 Tesla MRI, 7T MRIUndergo 7T MRI | Procedure or surgery | Diagnostic (7T MRI) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (7T MRI) |
Primary outcome
Contrast-to-noise Ratio (CNR)
Time frame: 1 year
Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink 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. This study is not recruiting at the moment.
Max Wintermark 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?
A study testing 7 Tesla Magnetic Resonance Imaging and Questionnaire Administration in people with Central Nervous System Neoplasm and Glioma, 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 18 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: finished, as of the sponsor's last update on 8 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-to-noise Ratio (CNR) (time frame: 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 8 Jan 2025.