Contrast Enhancement in Magnetic Resonance ImagingPhase 3Quanti CNSNCT05915702
A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems
A Phase 3 study testing Gadoquatrane (BAY1747846), Gadobutrol and Gadoterate meglumine in people with Contrast Enhancement in Magnetic Resonance Imaging and Central Nervous System Pathology, run by Bayer at 78 sites in 15 countries.
Trial summary
Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Enhancement in Magnetic Resonance Imaging, Central Nervous System Pathology
- What is being tested?
- Gadoquatrane (BAY1747846), Gadobutrol and Gadoterate meglumine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 78 sitesin 15 countries
- Study dates
- 24 Jul 2023to 31 May 2024
- Phase
- Phase 3
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
- Participant must be >= 18 years of age inclusive, at the time of signing the informed consent form
- Participants with a clinical indication for a contrast-enhanced MRI (including MRA), with any approved standard of care macrocyclic GBCA with proven efficacy, safety and tolerability in clinical routine CE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that is used at the site for the indication, for a known or suspected CNS pathology
- Participants who can undergo study-related procedures, including 2 contrast-enhanced MRI examinations (one with gadoquatrane and one with a comparator macrocyclic GBCA), as per participant and Investigator's judgement
- Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum of 24 hours after the last dose of study intervention)
Who cannot join
- Considered clinically unstable or has a concurrent/concomitant condition that may significantly alter image comparability between the 2 study MRIs or between study parameters (e.g. safety, pharmacokinetics [PK] parameters) or would not allow participation for the full planned study period, in the judgement of the investigator
- Participants presenting with severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2, derived from a serum or plasma creatinine sample obtained within 48 hours prior to the first contrast agent injection in the study
- Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR
- History of moderate to severe allergic-like reaction to any GBCA
- Bronchial asthma considered unstable or who have had recent modification to their medical therapy
- Receipt of any contrast agent < 72 h prior to the study MRIs or planned to receive any contrast agent during the trial until 24 h +/- 4 h after the second study MRI
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- Planned or expected interventional diagnostic or therapeutic procedure (e.g. biopsy or surgery in the region of interest) or change in treatment (e.g. start of chemotherapy or antiangiogenic therapy, significant change in corticosteroids dose) that may significantly alter image comparability between the 2 MRIs or other study parameters (i.e. safety/adverse events (AEs) [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters), from the first study MRI up to 24 h after the second study MRI
- Has received any investigational product within 30 days, or within 5 times half-life of the investigational product, whatever is shorter, prior to or concurrent with this study
- Contraindications to the administration of macrocyclic GBCAs (depending on local product label), or history of adverse reaction to gadoquatrane
- Any contraindication to MRI examinations based on institution policy and investigator's clinical judgement (e.g. some metallic implants or active implants)
Trial locations and contacts
78 sites in 15 countries.
78 sites in 15 countries
Japan10 sites
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, 811-0213
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
Kanazawa, Ishikawa-ken, 920-8650
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
Kure Kyosai Hospital
Kure, Hiroshima, 737-8505
Japan Organization of Occupational Health and Safety Kagawa Rosai Hospital
Marugame, Kagawa-ken, 763-8502
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, 662-0918
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Osaka, Osaka, 534-0021
National Hospital Organization Kanmon Medical Center
Shimonoseki, Yamaguchi, 752-8510
China9 sites
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Peking University First Hospital - Oncology Department
Beijing, Beijing Municipality, 100034
Beijing Tiantan Hospital, Captial Medical University
Beijing, Beijing Municipality, 100050
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, 510120
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
United States8 sites
Northwestern Memorial Hospital - Radiology
Chicago, Illinois, 60611
MU Health Care - University Hospital - Radiology
Columbia, Missouri, 65212
Duke University School of Medicine - Early Phase Research Unit - Neurology
Durham, North Carolina, 27710
QUEST Research Institute | Farmington Hills, MI
Farmington Hills, Michigan, 48334
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Halo Diagnostics - Indian Wells
Indian Wells, California, 92210
Biogenix Molecular, LLC
Miami, Florida, 33165
University of California Irvine Med. Center / Diagnostic Radiology, Neuroradiology
Orange, California, 92868
Bulgaria8 sites
Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
Plovdiv, Plovdiv Province, 4002
University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
Plovdiv, Plovdiv Province, 4002
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, Sofia City Province, 1407
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
Sofia, Sofia City Province, 1431
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD
Sofia, Sofia City Province, 1431
University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
Sofia, Sofia City Province, 1431
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
Sofia, Sofia City Province, 1784
MHAT Sveta Marina EAD
Varna, Varna Province, 9010
Argentina6 sites
Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
CABA, Ciudad Auton. de Buenos Aires, C1426
Sanatorio Otamendi | Imaging Diagnostic Center
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1115AAB
Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, C1425BEE
Sanatorio Allende | Departamento de Investigación Clínica
Córdoba, Córdoba Province, X5000JHQ
Clinica Universitaria Reina Fabiola | Consultorios Externos
Córdoba, Córdoba Province, X5004FHP
Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
Lomas de Zamora, Buenos Aires, B1832BRQ
Czechia6 sites
Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny
Brno, South Moravian, 625 00
Fakultní nemocnice Ostrava
Ostrava - Poruba, 708 52
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
Pardubice, 530 03
Fakultni nemocnice Plzen - Lochotin
Pilsen, 32300
Všeobecná fakultní nemocnice v Praze
Prague, 12808
Fakultní Thomayerova nemocnice - RDG radiodiagnostické oddelení
Prague, 14059
Turkey (Türkiye)6 sites
Hacettepe Universitesi Tip Fakultesi
Ankara, 6100
Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
Erzincan, 24100
Koc Universitesi Tip Fakultesi - Radyoloji
Istanbul, 34010
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
Istanbul, 34098
Ondokuz Mayis Uni Tip Fakultesi
Samsun, 55139
Germany4 sites
Uniklinik Augsburg / Radiologie
Augsburg, Bavaria, 86156
Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21181
Essen, North Rhine-Westphalia, 45147
Uniklinik Kiel /Radiologie und Neuroradiologie
Kiel, Schleswig-Holstein, 24105
St. Franziskus-Hospital GmbH
Münster, North Rhine-Westphalia, 48145
Hungary4 sites
Debreceni Egyetem Klinikai Kozpont - Idegsebeszeti Klinika
Debrecen, 4032
Szent Damján Görögkatolikus Kórház - Neurologiai es Stroke Osztaly
Kisvárda, 4600
Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
Pécs, 7623
Trial Pharma Kft. Szeged
Szeged, 6726
France3 sites
Center Hospitalier Michallon - Grenoble
La Tronche, Auvergne-Rhône-Alpes, 38043
Centre Hospitalier Lyon Sud - Service d'imagerie
Pierre-Bénite, Auvergne-Rhône-Alpes, 69310
Centre Hospitalo-Universitaire de Strasbourg
Strasbourg, Grand Est, 67200
Italy3 sites
ASL Della Provincia Di Barletta Andria Trani_Ospedale L.Bonomo - Radiodiagnostica
Andria, Apulia, 76123
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Radiologia diagnostica per immagini 2 Neuroradiologia
Bergamo, Lombardy, 24127
Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neuroradiologia
Rome, Lazio, 00189
South Korea3 sites
Inje University Busan Paik Hospital
Busan, 47392
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi, 05030
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080
Sweden3 sites
Karolinska Universitetssjukhuset - Huddinge - Neuroradiologi
Stockholm, Stockholm County, 141 86
Karolinska Universitetssjukhuset - Solna - Neuroradiologi
Stockholm, Stockholm County, 171 77
Akademiska sjukhuset i Uppsala - Röntgen (bild- och funktionsmedicinskt centrum)
Uppsala, Uppsala County, 701 85
United Kingdom3 sites
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, Wales, CF14 4XW
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
Charing Cross Hospital
London, Greater London, W6 8RF
Canada2 sites
University Hospital | Medical Imaging
London, Ontario, N6A 5A5
Hôpital du Sacré-Cœur de Montréal | Radiology
Montreal, Quebec, H4J 1C5
About this study
Official title: A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)
Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
Read more
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
- take blood and urine samples
- do physical examinations
- check blood pressure and heart rate
- review the MRI scans obtained in the study and decide on the diagnosis
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
- Being tested
- Gadoquatrane (BAY1747846), Gadobutrol, Gadoterate meglumine, Gadoteridol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoquatrane (BAY1747846)Drug
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose
GadobutrolDrug
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
Gadoterate meglumineDrug
Also called Gadoteric acid
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
GadoteridolDrug
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| Gadoquatrane - Approved Macrocyclic GBCA | Experimental | Participants will receive one intravenous injection of gadoquatrane before or during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 2. Receives: Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol |
| Approved Macrocyclic GBCA - Gadoquatrane | Experimental | Participants will receive one intravenous injection of any approved macrocyclic GBCA before or during MRI in Period 1, followed by one intravenous injection of gadoquatrane before or during MRI in Period 2. Receives: Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR (Mean Score)
contrast enhancement was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Contrast enhancement was rated on a 4-point scale (1 = not enhanced; 2 = weakly enhanced; 3 = clearly enhanced; 4 = clearly and brightly enhanced), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR (Mean Score)
Delineation was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Delineation was rated on a 4-point scale (1 = no or unclear delineation; 2 = moderate delineation, with some aspects visible; 3 = good delineation, almost clear but not complete; 4 = excellent delineation, clear and complete), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR (Mean Score)
Morphology was assessed by blinded independent central review (BICR) readers using separate blinded evaluations of unenhanced MRI image sets and combined pre- and post-contrast gadoquatrane MRI image sets. Morphology was rated on a 3-point scale (1 = poor: no or poorly evaluable; 2 = moderate: partially evaluable; 3 = good: sufficiently evaluable), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Secondary outcomes (14)
Visualization Parameter Contrast Enhancement Assessed by Blinded Independent Central Review (BICR) Readers on Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs (Mean Score)
Contrast enhancement was assessed by blinded independent central review (BICR) readers on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Enhancement was rated using a 4-point scale (1 = not enhanced; 2 = weakly enhanced; 3 = clearly enhanced; 4 = clearly and brightly enhanced), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Visualization Parameter Delineation Assessed by Blinded Independent Central Review (BICR) Readers on Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs (Mean Score)
Delineation was assessed by blinded independent central review (BICR) readers on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Delineation was rated using a 4-point scale (1 = no or unclear delineation; 2 = moderate delineation; 3 = good delineation; 4 = excellent delineation), and mean scores with standard deviation are reported
Measured: 1 day procedure
Visualization Parameter Morphology Assessed by Blinded Independent Central Review (BICR) Readers on Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs (Mean Score)
Morphology was assessed by blinded independent central review (BICR) readers on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Morphology was rated on a 3-point scale (1 = poor: no or poorly evaluable; 2 = moderate: partially evaluable; 3 = good: sufficiently evaluable), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Sensitivity (%) for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Sensitivity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion classifications were compared with the composite Standard of Truth (SoT), and sensitivity with corresponding 95% confidence intervals was calculated.
Measured: 1 day procedure
Specificity (%) for the Detection of Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Specificity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion classifications were compared with the composite Standard of Truth (SoT), and specificity with corresponding 95% confidence intervals was calculated.
Measured: 1 day procedure
Mean Overall Diagnostic Clinical Value Score From Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
Overall diagnostic clinical value was assessed by blinded independent central review (BICR) readers based on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Clinical value was rated using a 5-point scale (1 = no diagnostic clinical value to 5 = excellent diagnostic clinical value), reflecting diagnostic performance and impact on patient management. Mean scores with standard deviation are reported.
Measured: 1 day procedure
Sensitivity (%) for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Sensitivity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (SoT), and sensitivity with corresponding 95% confidence intervals was calculated.
Measured: 1 day procedure
Specificity (%) for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
Specificity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (SoT), and specificity with corresponding 95% confidence intervals was calculated.
Measured: 1 day procedure
Number of Cases With Concordance Between Final Diagnosis and MRI Diagnosis From Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs, as Assessed by the Investigator
The investigator or designee, who remained blinded to the contrast agent used, assessed the diagnosis based on combined pre- and post-contrast MRI image sets for each period. Concordance between the MRI-based diagnosis and the final clinical diagnosis was evaluated, and the number of cases with matching and non-matching diagnoses was summarized.
Measured: 1 day procedure
Mean Confidence in Diagnosis Score From Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator on 4PS
Confidence in diagnosis was assessed by blinded independent central review (BICR) readers and the investigator to determine the level of certainty in the assigned diagnosis based on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Confidence was scored using a 4-point scale (1 = Not confident, 2 = Somewhat confident, 3 = Confident, 4 = Very confident), and mean scores with standard deviation are reported.
Measured: 1 day procedure
Mean Number of Lesions Seen on Unenhanced MRI Image Set and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Determination of the mean number of lesions visualized on the combined CE-MR image sets for gadoquatrane and SoC GBCAs, in comparison to the respective pre-contrast MRI, assessed by blinded independent central review (BICR).
A lesion is defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of medical imaging, it is defined as the localization of a pathology which might be visualized on the MRI; the term lesion will be used when referring to a pathology noted on the MR image.
Measured: 1 day procedure
Number of Enhancing Lesions Seen on Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
Evaluation of any differences in the number of enhancing lesions between the combined gadoquatrane and SoC GBCA MR image sets, as assessed by blinded independent central review (BICR) readers
Measured: 1 day procedure
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Treatment-emergent adverse events (AEs), including serious adverse events, are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection)
Measured: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Number of Participants With Treatment Emergent Adverse Events, Per Intensity, After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
Treatment-emergent (serious) AEs are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection). Participants with at least one treatment-emergent adverse event are counted once and categorized according to the maximum intensity of their adverse events (mild, moderate, or severe), as assessed by the investigator.
Measured: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start24 Jul 2023
- Primary completion30 May 2024
- Study completion31 May 2024
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 Contrast Enhancement in Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915702
- Sponsor's protocol ID
- 21181
- Other IDs
- 2022-501884-41-00
- Acronym
- Quanti CNS
- Status last verified
- Sep 2026
- First submitted
- 14 Jun 2023
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.