Brain NeoplasmNCT04132843
Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions
A study testing Gadobenate Dimeglumine, Gadobutrol and Magnetic Resonance Imaging in people with Brain Neoplasm and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasm, Lymphoma, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Gadobenate Dimeglumine, Gadobutrol and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
- Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
- Patient is able to understand and give own consent to participate in the study
Who cannot join
- Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
- Contraindication or history of allergy to Gadolinium-based (gadobutrol [Gadovist], gadobenate dimeglumine (Multihance]) intravenous contrast
- Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
- Prior partial (greater than 50%) or gross total resection of primary tumor
- Prior chemotherapy or radiation treatment to brain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
This trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To use 3-dimensional (3D) quantitative mapping to determine whether differences in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere at baseline.
II. To use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment.
SECONDARY OBJECTIVES:
- Determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment.
II. Quantify T1 and proton density (PD) spin parameters of the peritumoral area and their differences before and after treatment.
III. Examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast (DSC) technique.
IV. Examine differences in measured perfusion parameters (blood volume and mean transit time of each tumor) before and after treatment.
OUTLINE:
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine intravenously (IV) and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
- Conditions
- Brain Neoplasm, Lymphoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
- Being tested
- Gadobenate Dimeglumine, Gadobutrol, Magnetic Resonance Imaging
- Medical subject headings
- Brain Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobenate DimeglumineDrug
Also called Gd-BOPTA, MultiHance
Given IV
GadobutrolDrug
Also called BAY86-4875, Gadavist, Gadograf, Gadovist
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (MRI, gadobutrol, gadobenate dimeglumine) | Experimental | Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy. Receives: Drug: Gadobenate Dimeglumine; Drug: Gadobutrol; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in T2 spin parameters
Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
Measured: Baseline
Differences between peritumoral and normal brain
Will use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment. The regions of interest drawn on measured magnetic resonance (MR) spin parameter and MR perfusion parameter values will be grouped according to time point (pre- or post-treatment) and area (peritumoral, tumoral, and normal brain in the contralateral hemisphere). Descriptive statistics and boxplots of these measurements, paired differences between areas and paired differences between time points will be calculated. Will calculate 95% confidence intervals around the mean paired change between area differences at baseline and post-treatment.
Measured: Baseline up to 120 days
Secondary outcomes (4)
Usefulness of T2 values in distinguishing non-enhancing components of the tumor
Will use area under an receive operating curve to determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment. Paired data from all patients will be used in this analysis.
Measured: Up to 120 days
Quantification of T1 and proton density (PD) parameters
Will quantify T1 and PD spin parameters of the peritumoral area and their differences before and after treatment.
Measured: Baseline up to 120 days
Post-contrast T1 spin parameters with perfusion characteristics
Will examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast technique.
Measured: Up to 120 days
Differences in measured perfusion parameters before and after treatment.
Will examine differences in measured perfusion parameters before and after treatment.
Measured: Baseline up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start10 Jan 2020
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain 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
- 6 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
- Ken-Pin Hwang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132843
- Sponsor's protocol ID
- 2019-0324
- Other IDs
- NCI-2019-05781, 2019-0324
- Status last verified
- Nov 2022
- First submitted
- 5 Sep 2019
- Last updated
- 21 Nov 2022
- 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 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multi-Parameter Mapping and Analysis Techniques for Characterization and Treatment Assessment of High Grade Brain Lesions
- ClinicalTrials.gov ID
- NCT04132843
- Acronym / sponsor ID
- 2019-0324
- Conditions
- Brain Neoplasm, Lymphoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Malignant Brain Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Oct 2019 (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.
This trial studies different magnetic resonance imaging (MRI) techniques and their ability to provide clearer pictures of lesions in patients with high grade brain lesions. An MRI is a type of imaging scan. Using different MRI techniques to produce clearer images of the brain may help researchers learn about the features of brain lesions and the effects of chemotherapy and/or radiation therapy.
Detailed description
PRIMARY OBJECTIVES:
- To use 3-dimensional (3D) quantitative mapping to determine whether differences in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere at baseline.
II. To use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment.
SECONDARY OBJECTIVES:
- Determine whether T2 values might be useful in distinguishing non-enhancing components of the tumor as well as predicting response to treatment.
II. Quantify T1 and proton density (PD) spin parameters of the peritumoral area and their differences before and after treatment.
III. Examine post-contrast T1 spin parameters with perfusion characteristics as measured by an established dynamic susceptibility contrast (DSC) technique.
IV. Examine differences in measured perfusion parameters (blood volume and mean transit time of each tumor) before and after treatment.
OUTLINE:
Within 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine intravenously (IV) and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI, gadobutrol, gadobenate dimeglumine) | Experimental | Drug: Gadobenate Dimeglumine, Drug: Gadobutrol, Procedure: Magnetic Resonance ImagingWithin 21 days before standard of care chemotherapy and/or radiation therapy, patients undergo an MRI scan for the first set of images. Patients then receive either gadobutrol or gadobenate dimeglumine IV and undergo an MRI for the second set of images. All MRI scans take a total of 60 minutes to complete. Patients then repeat the MRI scans 120 days after standard of care chemotherapy and/or radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one enhancing lesion, aggregate of enhancing foci, and nonenhancing lesion measuring at least 1 cm in size and is suspected to be a high grade brain neoplasm
- Patient is dispositioned to surgery, chemotherapy and/or radiation therapy
- Patient is able to understand and give own consent to participate in the study
Key exclusion criteria (5 listed)
- Contraindication to magnetic resonance imaging (MRI) as assessed by our standard of care magnetic resonance (MR) screening procedure, which includes implants or devices that are unsafe in the magnetic environment
- Contraindication or history of allergy to Gadolinium-based (gadobutrol [Gadovist], gadobenate dimeglumine (Multihance]) intravenous contrast
- Verbal confirmation of pregnancy or a positive pregnancy test result in patient record
- Prior partial (greater than 50%) or gross total resection of primary tumor
- Prior chemotherapy or radiation treatment to brain
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 |
|---|---|---|
| Gadobenate DimeglumineAlso: Gd-BOPTA, MultiHanceGiven IV | Drug | Diagnostic (MRI, gadobutrol, gadobenate dimeglumine) |
| GadobutrolAlso: BAY86-4875, Gadavist, Gadograf, GadovistGiven IV | Drug | Diagnostic (MRI, gadobutrol, gadobenate dimeglumine) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR ImagingUndergo MRI | Procedure or surgery | Diagnostic (MRI, gadobutrol, gadobenate dimeglumine) |
Primary outcome
Differences in T2 spin parameters
Time frame: Baseline
Will use 3-dimensional (3D) quantitative mapping to determine whether different in T2 spin parameters exist between the peritumoral area and normal brain in the contralateral hemisphere. If the data are normal, will calculate 95% confidence intervals around the mean paired difference in baseline T2 between the peritumoral and normal regions. If the data are not normally distributed, ordered statistics will be calculated, and bootstrapping will be used to estimate the 2.5th and 97.5th percentiles for the median.
Differences between peritumoral and normal brain
Time frame: Baseline up to 120 days
Will use 3D quantitative mapping to examine how differences between peritumoral and normal brain in the contralateral hemisphere change before and after treatment. The regions of interest drawn on measured magnetic resonance (MR) spin parameter and MR perfusion parameter values will be grouped according to time point (pre- or post-treatment) and area (peritumoral, tumoral, and normal brain in the contralateral hemisphere). Descriptive statistics and boxplots of these measurements, paired differences between areas and paired differences between time points will be calculated. Will calculate 95% confidence intervals around the mean paired change between area differences at baseline and post-treatment.
4 secondary outcomes
Usefulness of T2 values in distinguishing non-enhancing components of the tumor
Time frame: Up to 120 days
Quantification of T1 and proton density (PD) parameters
Time frame: Baseline up to 120 days
Post-contrast T1 spin parameters with perfusion characteristics
Time frame: Up to 120 days
Differences in measured perfusion parameters before and after treatment.
Time frame: Baseline up to 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- M D Anderson Cancer CenterLink 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.
Ken-Pin Hwang, MD 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 Gadobenate Dimeglumine, Gadobutrol and Magnetic Resonance Imaging in people with Brain Neoplasm and Lymphoma, 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 3 inclusion and 5 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 21 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in T2 spin parameters (time frame: Baseline). The study lists 2 primary outcomes in all. 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 21 Nov 2022.