Central Nervous System NeoplasmsNCT02095353
Comparison of Contrast Agents for MRI Perfusion Analysis in Brain Tumor Patients
An observational study of Central Nervous System Neoplasms, run by University of Nebraska at 1 site in United States.
Trial summary
This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Central Nervous System Neoplasms
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 7 Mar 2017
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with brain tumors who have had a brain MRI ordered.
Who may be able to join
- Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.
Who cannot join
- Renal failure (GFR <45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
- Allergic reactions to MRI contrast agents.
- Subjects who do not fit the criteria for the population we are evaluating.
- Subjects should not participate in this study if they have any of the following conditions:
- Anxiety attacks
- Panic disorder
Show all 11Show fewer
- Claustrophobia
- Pregnant, or trying to become pregnant
- Breast feeding
- Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
- If a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical MRI examination to safely perform the research MRI examination that subject would be excluded.Subjects not being able to return for a follow-up examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198-1045
About this study
Official title: Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients
This study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.
Read the detailed description
This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.
- Conditions
- Central Nervous System Neoplasms
- Keywords
- Brain tumor, extraaxial, metastasis, glioma, primary brain tumor, secondary brain tumor, MRI, perfusion, dynamic contrast enhancement, CBV, CBF, ktrans
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Neoplasm Metastasis, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of contrast induced signal changes with dynamic imaging of brain tumors
Two contrast agents will be administered in different MRI imaging sessions. Will measure how the appearance of brain tumors change during dynamic first pass contrast administration.
Measured: 2 weeks
Secondary outcomes (1)
Calculate differences in cerebral blood volume, ktrans and flow in brain tumors
Calculations will be made of cerebral blood volume, cerebral blood flow or ktrans in brain tumors when different contrast agents are administered. These parameters reflect vasculature and angiogenesis in tumors.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study start1 Sep 2014
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Why it stopped: FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew White, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095353
- Sponsor's protocol ID
- 0585-13-FB
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2014
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gadobenate Dimeglumine Compared to Gadobutrol for MRI Perfusion Analysis in Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT02095353
- Acronym / sponsor ID
- 0585-13-FB
- Conditions
- Central Nervous System Neoplasms
- Keywords
- Brain tumor, extraaxial, metastasis, glioma, primary brain tumor, secondary brain tumor, MRI, perfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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 study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.
Detailed description
This study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for MRI perfusion analysis in brain tumor patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with brain tumors who have had a brain MRI ordered.
Key inclusion criteria (1 listed)
- Subjects with brain tumors will be enrolled. These subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. If a subject has undergone surgery or treatment they should have what appears to be residual tumor.
Key exclusion criteria (11 listed)
- Renal failure (GFR <45). Subjects will be screened utilizing UNMC gadolinium contrast guidelines.
- Allergic reactions to MRI contrast agents.
- Subjects who do not fit the criteria for the population we are evaluating.
- Subjects should not participate in this study if they have any of the following conditions:
- Subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. Our standard MRI safety screening will be performed on all subjects.
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
Degree of contrast induced signal changes with dynamic imaging of brain tumors
Time frame: 2 weeks
Two contrast agents will be administered in different MRI imaging sessions. Will measure how the appearance of brain tumors change during dynamic first pass contrast administration.
1 secondary outcome
Calculate differences in cerebral blood volume, ktrans and flow in brain tumors
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Central Nervous System Neoplasms
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Matthew White, MD principal investigator
University of Nebraska
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 Central Nervous System Neoplasms, run by University of Nebraska 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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 Aug 2023. 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 was stopped early (reason given: FDA safety concerns with repeated use of gadolinium-based contrast; subjects received additional dose of contrast with no direct clinical benefit). Results are not available in the source record.
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?
Degree of contrast induced signal changes with dynamic imaging of brain tumors (time frame: 2 weeks). 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 23 Aug 2023.