Brain DiseasePhase 4TRUTHNCT01613417
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
A Phase 4 study testing gadoteridol and gadobutrol in people with Brain Disease, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Disease
- What is being tested?
- gadoteridol and gadobutrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2014
- 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
- Are scheduled to undergo MRI
- Are willing to undergo two MRI procedures within 14 days
- Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
- Clinical/neurological symptomatology;
- Diagnostic testing, such as CT or previous MRI examinations; or
- Have had previous brain surgery and are to be evaluated for recurrence.
Who cannot join
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- by testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
- by history (i.e., tubal ligation or hysterectomy); or
- post menopausal with a minimum of 1 year without menses
- Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
- Have congestive heart failure (class IV according to the classification of the New York Heart Association; see Appendix A)
Show all 17Show fewer
- Have suffered a stroke within a year
- Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2
- Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product.
- Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 45 mL/min.
- Have been previously entered into this study
- Have received or are scheduled for one of the following:
- Surgery within three weeks prior to the first examination or between the two examinations
- Initiation of steroid therapy between the two examinations
- Radiosurgery between the two examinations
- Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
- Are suffering from severe claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
Read the detailed description
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.
- Conditions
- Brain Disease
- Being tested
- gadoteridol, gadobutrol
- Keywords
- Have confirmed or are highly suspected of brain disease
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoteridolDrug
Also called ProHance
ProHance 0.1 mmol/kg
gadobutrolDrug
Also called Gadovist, Gadavist
Gadovist/Gadavist 0.1 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| MRI with Gadoteridol | Active comparator | MRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences. Receives: Drug: gadoteridol; Drug: gadobutrol |
| MRI with Gadobutrol | Active comparator | MRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences. Receives: Drug: gadoteridol; Drug: gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Diagnostic Preference Between the Two Exams
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Measured: Comparison of image sets obtained within 2 to 14 days
Secondary outcomes (8)
Lesion Border Delineation
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion Internal Morphology
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Measured: Comparison of image sets obtained within 2 to 14 days
Extent of Disease
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion Contrast Enhancement
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Measured: Comparison of image sets obtained within 2 to 14 days
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)
Measured: 5-10 minutes Postdose
Percentage Signal Intensity Enhancement on Postdose Images
Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)
Measured: 5-10 minutes Postdose
Lesion Detection
Lesion detection rate by contrast agent and reader
Measured: 5-10 minutes Postdose
Accuracy for Tumor Characterization
Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment
Measured: 5-10 minutes Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionApr 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianpaolo Pirovano, MD, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613417
- Sponsor's protocol ID
- PH-107
- Acronym
- TRUTH
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2012
- Last updated
- 1 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Zizka J, Colosimo C, Urbanczyk-Zawadzka M, Mechl M, Bag AK, Bastianello S, Bueltmann E, Hirai T, Frattini T, Kirchin MA, Pirovano G. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015 Jan;36(1):14-23. doi: 10.3174/ajnr.A4154. Epub 2014 Oct 9.
PubMed 25300984
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Double-blind, Multi-center, Randomized, Crossover Study to Compare 0.1 mmol/kg of Prohance® With 0.1 mmol/kg of Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain (TRUTH)
- ClinicalTrials.gov ID
- NCT01613417
- Acronym / sponsor ID
- TRUTH / PH-107
- Conditions
- Brain Disease
- Keywords
- Have confirmed or are highly suspected of brain disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
Detailed description
Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI with Gadoteridol | Active comparator | Drug: gadoteridol, Drug: gadobutrolMRI after 0.1 mmol/kg IV ProHance, then with 0.1 mmol/kg Gadovist/Gadavist. MRI performed after both agents with identical sequences. |
| MRI with Gadobutrol | Active comparator | Drug: gadoteridol, Drug: gadobutrolMRI after 0.1 mmol/kg IV Gadovist/Gadavist, then with 0.1 mmol/kg ProHance. MRI performed after both agents with identical sequences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are scheduled to undergo MRI
- Are willing to undergo two MRI procedures within 14 days
- Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
- Clinical/neurological symptomatology;
- Diagnostic testing, such as CT or previous MRI examinations; or
Key exclusion criteria (17 listed)
- Are pregnant or lactating females. Exclude the possibility of pregnancy:
- by testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
- by history (i.e., tubal ligation or hysterectomy); or
- post menopausal with a minimum of 1 year without menses
- Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
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 |
|---|---|---|
| gadoteridolAlso: ProHanceProHance 0.1 mmol/kg | Drug | MRI with Gadobutrol, MRI with Gadoteridol |
| gadobutrolAlso: Gadovist, GadavistGadovist/Gadavist 0.1 mmol/kg | Drug | MRI with Gadobutrol, MRI with Gadoteridol |
Primary outcome
Global Diagnostic Preference Between the Two Exams
Time frame: Comparison of image sets obtained within 2 to 14 days
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
8 secondary outcomes
Lesion Border Delineation
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion Internal Morphology
Time frame: Comparison of image sets obtained within 2 to 14 days
Extent of Disease
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion Contrast Enhancement
Time frame: Comparison of image sets obtained within 2 to 14 days
Lesion to Background Ratio on Post T1-weighed Spin Echo Images
Time frame: 5-10 minutes Postdose
Percentage Signal Intensity Enhancement on Postdose Images
Time frame: 5-10 minutes Postdose
Lesion Detection
Time frame: 5-10 minutes Postdose
Accuracy for Tumor Characterization
Time frame: 5-10 minutes Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25300984Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Zizka J, Colosimo C, Urbanczyk-Zawadzka M, Mechl M, Bag AK, Bastianello S, Bueltmann E, Hirai T, Frattini T, Kirchin MA, Pirovano G. Are there differences between macrocyclic gadolinium contrast agents for brain tumor imaging? Results of a multicenter intraindividual crossover comparison of gadobutrol with gadoteridol (the TRUTH study). AJNR Am J Neuroradiol. 2015 Jan;36(1):14-23. doi: 10.3174/ajnr.A4154. Epub 2014 Oct 9.
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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.
Gianpaolo Pirovano, MD study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gadoteridol and gadobutrol in people with Brain Disease, run by Bracco Diagnostics, Inc 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 17 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 1 Jul 2015. 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.
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 3 Jun 2015). 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?
Global Diagnostic Preference Between the Two Exams (time frame: Comparison of image sets obtained within 2 to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01613417, which also lists 1 linked publication.
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 1 Jul 2015.