Primary Brain TumorPhase 4REMINDNCT02034708
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
A Phase 4 study testing Dotarem® and Gadovist®/Gadavist® in people with Primary Brain Tumor, run by Guerbet at 32 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumor
- What is being tested?
- Dotarem® and Gadovist®/Gadavist®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 32 sitesin 4 countries
- Study dates
- Jun 2014to Sep 2015
- Phase
- Phase 4
- 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
- Female or male adult patient (patient having reached legal majority age)
- Patient with known or highly suspected primary intracranial tumors (intra-axial or extra-axial) detected by previous CT or MRI examination who are scheduled to undergo a routine contrast-enhanced MRI
- Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
- Patient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conducted
- Patient with national health insurance (according to local regulatory requirements)
Who cannot join
- Patient with rapidly evolving brain tumor that could change in appearance between the time of the two study MRI examinations.
- Patient undergoing current or recent treatment within past 6 weeks or scheduled for any treatment that could results in changes of lesion appearance between the two study examinations. This would include, but not restricted to, the following: current or recent radiation therapy, surgery, starting or recent chemotherapy.
- Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to the imaging site standard practice)
- Patient with known severely impaired renal function (defined as eGFR MDRD< 30 ml/min/1.73m2)
- Patient with known Class III/IV congestive heart failure according to the New York Heart Association classification
- Patient with known severe adverse drug reaction or contraindication to Gadolinium-Based Contrast Agent
Show all 12Show fewer
- Patient having received any contrast agent within 48 hours prior to first study contrast agent injection scheduled for the study and patient expected to receive any other contrast agent within 24 hours of the last study contrast agent injection
- Patient presenting with any condition which, based on the investigator's clinical judgment, would prevent the patient from completing all trial assessments and visits
- Patient under guardianship and/or unable or unwilling to cooperate with the requirements of this trial
- Pregnant or breast feeding female patient
- Patient already included in this trial
- Patient included in another clinical trial involving an IMP within 30 days before the first investigational contrast agent injection.
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States14 sites
University of Michigan Health System
Ann Arbor, Michigan
University of Alabama at Birmingham
Birmingham, Alabama
UVM MRI Center for Biomedical Imaging
Burlington, Vermont
MUSC (Medical University of South Carolina)
Charleston, South Carolina
Quest Research Institute
Farmington Hills, Michigan
Spectrum Health
Grand Rapids, Michigan
Infinity Clinical Research, LLC
Hollywood, Florida, FL 33021
Cedars-Sinai Medical Center
Los Angeles, California
Winthrop University Hospital Clinical Trials Center
Mineola, New York, NY 11501
Yale University School Of Medicine
New Haven, Connecticut
Temple University Hospital
Philadelphia, Pennsylvania
University of Washington Medical Center
Seattle, Washington
Washington University
St Louis, Missouri
University of Arizona Medical Center
Tucson, Arizona, AZ 85724
Mexico7 sites
Hospital CIMA
Chihuahua City, Chihuahua, 31238
Morales Vargas Centro de Investigación S.C.
León, Guanajuato, 37000
Centro Neurologico ABC
México, Mexico Distrito Federal, 5300
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64020
Winsett Rethman S.A. de C.V.
Monterrey, Nuevo León
Centro Regiomontano de Investigacion S.C.
Monterrey
Clinical Research Institute S.C.
Tlanepantla
Colombia6 sites
Fundacion Abood Shaio
Bogotá
Fundacion Cardioinfantil Instituto de Cardiologia
Bogotá
Instituto Nacional de Cancerologia
Bogotá
Centro Medico Imbanaco
Cali
Fundacion Instituto de Alta Tecnologia Medica de Antioquia IATM
Medellín
Hospital Pablo Tobon Uribe
Medellín
South Korea5 sites
Chungbuk National University
Cheongju-si, North Chungcheong, 361-711
Chonbuk national Univ Hosp
Jeonju, Jeollabuk-do, 561-712
Seoul St.Mary Hospital
Seoul, Seocho-gu, 137-701
Asan medical center
Seoul, Songpa-Gu, 138-736
Ajou University Hospital
Suwon
About this study
Official title: Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment).
270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between.
Read more
Each patient will, therefore, receive two MRI during his/her participation in the study.
The two arms consist in :
- Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.
- Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.
Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.
MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.
- Conditions
- Primary Brain Tumor
- Being tested
- Dotarem®, Gadovist®/Gadavist®
- Keywords
- Primary brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dotarem®Drug
Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
Gadovist®/Gadavist®Drug
Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
| Study group | Role | What they receive |
|---|---|---|
| Dotarem®/Gadovist® | Experimental | Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI Receives: Drug: Dotarem®; Drug: Gadovist®/Gadavist® |
| Gadovist®/Dotarem® | Experimental | Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI Receives: Drug: Dotarem®; Drug: Gadovist®/Gadavist® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale:
- Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion.
Measured: Up to 15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
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 Primary Brain TumorStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Maravilla, MD, Study chair, University of Washington Medical Center, Seattle, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034708
- Sponsor's protocol ID
- DGD-44-058
- Acronym
- REMIND
- Status last verified
- Nov 2016
- First submitted
- 10 Jan 2014
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Cross-over Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/ Gadavist®-Enhanced MRI in the Diagnosis of Brain Tumors
- ClinicalTrials.gov ID
- NCT02034708
- Acronym / sponsor ID
- REMIND / DGD-44-058
- Conditions
- Primary Brain Tumor
- Keywords
- Primary brain tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 25 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate non-inferiority of Dotarem®-enhanced MRI as compared to Gadovist®/ Gadavist®-enhanced MRI in the diagnosis of brain tumors in terms of overall lesion visualization and characterization (off-site assessment).
270 patients will be randomized between 2 arms defining the sequence of administration of the contrast agents at the dose of 0.1mmol/kg, with a minimum of 48 hours and a maximum of 14 days in between.
Each patient will, therefore, receive two MRI during his/her participation in the study.
The two arms consist in :
- Dotarem® in the first MRI, then Gadovist®/Gadavist® in the second MRI.
- Gadovist®/Gadavist® in the first MRI, then Dotarem® in the second MRI.
Contrast-enhanced MRIs will be performed on 1.5 or 3 Tesla systems.
MRI examinations will be evaluated centrally by blinded independent readers for the main evaluation criterion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotarem®/Gadovist® | Experimental | Drug: Dotarem®, Drug: Gadovist®/Gadavist®Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI |
| Gadovist®/Dotarem® | Experimental | Drug: Dotarem®, Drug: Gadovist®/Gadavist®Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male adult patient (patient having reached legal majority age)
- Patient with known or highly suspected primary intracranial tumors (intra-axial or extra-axial) detected by previous CT or MRI examination who are scheduled to undergo a routine contrast-enhanced MRI
- Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
- Patient having provided his/her written informed consent to participate in the trial prior to any study-related procedure being conducted
- Patient with national health insurance (according to local regulatory requirements)
Key exclusion criteria (12 listed)
- Patient with rapidly evolving brain tumor that could change in appearance between the time of the two study MRI examinations.
- Patient undergoing current or recent treatment within past 6 weeks or scheduled for any treatment that could results in changes of lesion appearance between the two study examinations. This would include, but not restricted to, the following: current or recent radiation therapy, surgery, starting or recent chemotherapy.
- Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to the imaging site standard practice)
- Patient with known severely impaired renal function (defined as eGFR MDRD< 30 ml/min/1.73m2)
- Patient with known Class III/IV congestive heart failure according to the New York Heart Association classification
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 |
|---|---|---|
| Dotarem®Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus. | Drug | Dotarem®/Gadovist®, Gadovist®/Dotarem® |
| Gadovist®/Gadavist®Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus. | Drug | Dotarem®/Gadovist®, Gadovist®/Dotarem® |
Primary outcome
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent
Time frame: Up to 15 days after randomization
Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale: 0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kenneth Maravilla, MD study chair
University of Washington Medical Center, Seattle, USA
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dotarem® and Gadovist®/Gadavist® in people with Primary Brain Tumor, run by Guerbet at 32 sites in 4 countries.
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 5 inclusion and 12 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Mexico, Colombia, South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2016). 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?
Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent (time frame: Up to 15 days after randomization). 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 30 Dec 2016.