CNS LesionPhase 3PICTURENCT03996447
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
A Phase 3 study testing gadopiclenol and Gadobutrol 1Mmol/mL Solution for Injection Vial in people with CNS Lesion and Blood Brain Barrier Defect, run by Guerbet at 33 sites in 11 countries.
Trial summary
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lesion, Blood Brain Barrier Defect
- What is being tested?
- gadopiclenol and Gadobutrol 1Mmol/mL Solution for Injection Vial
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 33 sitesin 11 countries
- Study dates
- 3 Jun 2019to 11 Sep 2020
- Phase
- Phase 3
- 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
- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
Who cannot join
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
- Patient presenting extra cranial lesions and/or extra-dural lesions.
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
United States8 sites
South Carolina Clinical & Translational Research (SCTR) Institute
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Missouri Hospital and Clinic
Columbia, Missouri, 65212
University of Connecticut Health Center
Farmington, Connecticut, 06030
ASCLEPES Research Centers
Panorama City, California, 91402
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Northwest Neurology, Ltd.
Rolling Meadows, Illinois, 600008
University Of Washington - Medical Center
Seattle, Washington, 98195
Hungary5 sites
Semmelweis Egyetem - Neurology
Budapest, 1083
Orszagos Klinikai Idegtudomanyi Intezet
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont
Debrecen
Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
Pécs, Pécs
Szegedi Tudomanyegyetem AOK
Szeged, 6725
France4 sites
CHRU - Hôpital Roger Salengro - Neurologie
Lille
Centre Hospitalier Sainte-Anne
Paris, 75014
CHU La Miletrie
Poitiers
CHRU Strasbourg Hôpital de Hautepierre
Strasbourg, 67098
Italy4 sites
ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore
L’Aquila
Fondazione I.R.C.C.S. C.Mondino
Pavia, 27100
Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.
Pozzilli, 86077
Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara
Trieste, 34149
Spain3 sites
Hospital del Mar
Barcelona, 08003
M.D. Anderson Cancer Center Madrid
Madrid, 28033
Hospital Clínico San Carlos
Madrid, 28040
Mexico2 sites
Axis Heilsa S. de R.L. de C.V. (Althian)
Monterrey, 64060
Clinical Research Institute S.C
Tlalnepantla, 54055
South Korea2 sites
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center
Seoul, 5505
Poland1 site
Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii
Gdansk, 80-214
About this study
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Read the detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging.
This is a multi-center, international, prospective, double-blind, randomized, controlled, cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.
This trial was conducted in 33 centers worldwide.
During the course of the trial, two MRIs were obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations were performed by on-site investigators and three independent off-site blinded readers.
- Conditions
- CNS Lesion, Blood Brain Barrier Defect
- Being tested
- gadopiclenol, Gadobutrol 1Mmol/mL Solution for Injection Vial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadopiclenolDrug
single intravenous (IV) bolus injection at a rate of 2ml/second
Gadobutrol 1Mmol/mL Solution for Injection VialDrug
single intravenous (IV) bolus injection at a rate of 2ml/second
| Study group | Role | What they receive |
|---|---|---|
| gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI | Other | cross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI Receives: Drug: gadopiclenol; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial |
| gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI | Other | cross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI Receives: Drug: gadopiclenol; Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader.
Measured: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
Secondary outcomes (1)
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.
Measured: At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start3 Jun 2019
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
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 CNS LesionStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorie Loevner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996447
- Sponsor's protocol ID
- GDX-44-010
- Acronym
- PICTURE
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2019
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Loevner LA, Kolumban B, Hutoczki G, Dziadziuszko K, Bereczki D, Bago A, Pichiecchio A. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313. doi: 10.1097/RLI.0000000000000944. Epub 2022 Dec 19.
PubMed 36729404
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT03996447
- Acronym / sponsor ID
- PICTURE / GDX-44-010
- Conditions
- CNS Lesion, Blood Brain Barrier Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Posted 22 Sep 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 aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol injection for Central Nervous System (CNS) lesion detection and visualization by conventional steady-state CNS imaging.
This is a multi-center, international, prospective, double-blind, randomized, controlled, cross-over with comparator trial in male and female patients presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) who are scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of the CNS.
This trial was conducted in 33 centers worldwide.
During the course of the trial, two MRIs were obtained from each patient: one unenhanced and gadopiclenol-enhanced MRI; and one unenhanced and gadobutrol-enhanced MRI. MRI evaluations were performed by on-site investigators and three independent off-site blinded readers.
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 |
|---|---|---|
| gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI | Other | Drug: gadopiclenol, Drug: Gadobutrol 1Mmol/mL Solution for Injection Vialcross-over design. each patient will receive gadopiclenol for the first MRI and gadobutrol for the second MRI |
| gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI | Other | Drug: gadopiclenol, Drug: Gadobutrol 1Mmol/mL Solution for Injection Vialcross-over design. each patient will receive gadobutrol for the first MRI and gadopiclenol for the second MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.
Key exclusion criteria (2 listed)
- Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
- Patient presenting extra cranial lesions and/or extra-dural lesions.
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 |
|---|---|---|
| gadopiclenolsingle intravenous (IV) bolus injection at a rate of 2ml/second | Drug | gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI, gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI |
| Gadobutrol 1Mmol/mL Solution for Injection Vialsingle intravenous (IV) bolus injection at a rate of 2ml/second | Drug | gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI, gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI |
Primary outcome
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
Time frame: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader.
1 secondary outcome
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
Time frame: At each of two MRI examinations with an interval of 2-14 days between 2 MRI examinations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36729404Loevner LA, Kolumban B, Hutoczki G, Dziadziuszko K, Bereczki D, Bago A, Pichiecchio A. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol. 2023 May 1;58(5):307-313. doi: 10.1097/RLI.0000000000000944. Epub 2022 Dec 19.
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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.
Lorie Loevner, MD principal investigator
University of Pennsylvania
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gadopiclenol and Gadobutrol 1Mmol/mL Solution for Injection Vial in people with CNS Lesion and Blood Brain Barrier Defect, run by Guerbet at 33 sites in 11 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 1 inclusion and 2 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Hungary, France, Italy, Spain and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Sep 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?
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI (time frame: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.). 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 NCT03996447, 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 22 Sep 2025.