AzTrials
AzTrials

Contrast Enhancement in Magnetic Resonance ImagingPhase 3Quanti OBRNCT05915728

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except 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 Non-central Nervous System Pathology, run by Bayer at 85 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers are looking for a better way to help people with any known or suspected problems (except 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
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
410 participants
Where
85 sitesin 16 countries
Study dates
24 Jul 2023to 1 Jun 2024
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

  • 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 magnetic resonance angiography [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, with known or suspected pathology of any body region, e.g. head and neck (except central nervous system [CNS]), thorax (including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper and lower.
  • 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
Show all 10Show fewer
  • 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

85 sites in 16 countries.

85 sites in 16 countries

Japan13 sites

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585

  • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office

    Hakusan, Ishikawa-ken, 924-8588

  • National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office

    Kanazawa, Ishikawa-ken, 920-8650

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-0042

  • JCHO Kyushu Hospital

    Kitakyushu, Fukuoka, 806-8501

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu, Fukuoka, 807-8556

  • Hyogo Prefectural Nishinomiya Hospital

    Nishinomiya, Hyōgo, 662-0918

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • National Hospital Organization Kanmon Medical Center

    Shimonoseki, Yamaguchi, 752-8510

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017

  • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

    Yonago, Tottori, 683-8605

Other trials in Japan

United States9 sites

  • UAB Hospital - Radiology

    Birmingham, Alabama, 35233

  • University of Missouri Hospital and Clinic - Neuroradiology

    Columbia, Missouri, 65212

  • Duke University School of Medicine - Early Phase Research Unit - Neurology

    Durham, North Carolina, 27710

  • University of Connecticut Health Center

    Farmington, Connecticut, 06032

  • Pennsylvania State University College of Medicine

    Hershey, Pennsylvania, 17033

  • Houston Methodist Hospital - Cardiology

    Houston, Texas, 77030

  • Halo Diagnostics - Indian Wells

    Indian Wells, California, 92210

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

  • UC Irvine Medical Center

    Orange, California, 92868

Other trials in United States

China9 sites

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University First Hospital - Oncology Department

    Beijing, Beijing Municipality, 100034

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • 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

Other trials in China

Bulgaria8 sites

  • University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department

    Pleven, Pleven Province, 5809

  • 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

  • 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

  • Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department

    Sofia, 1407

  • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department

    Sofia, 1784

Other trials in Bulgaria

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, Buenos Aires, B1832BRQ

Other trials in Argentina

Czechia6 sites

  • Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny

    Brno, South Moravian, 625 00

  • Fakultní nemocnice Ostrava - Radiodiagnostický ústav

    Ostrava, 708 00

  • 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 - klinicko-farmakologická jednotka

    Praha 4 - Krc, 140 00

Other trials in Czechia

Germany6 sites

  • Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT

    Berlin, State of Berlin, 13125

  • Uniklinik Bonn / Radiologie

    Bonn, North Rhine-Westphalia, 53127

  • Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197

    Essen, 45147

  • Uniklinik Freiburg / Radiologie

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie

    Göttingen, Lower Saxony, 37075

  • Helios Herzzentrum Leipzig - Abteilung für diagnostische und interventionelle Radiologie

    Leipzig, Saxony, 04289

Other trials in Germany

Turkey (Türkiye)5 sites

  • 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 Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi

    Samsun, 55139

Other trials in Turkey (Türkiye)

France4 sites

  • Centre Hospitalier Universitaire - Angers

    Angers, Pays de la Loire Region, 49933

  • Hospices Civils de LYON

    Bron, Auvergne-Rhône-Alpes, 69500

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079

  • Hôpital Bichat Claude Bernard - Service de radiologie

    Paris, Île-de-France Region, 75018

Other trials in France

Italy4 sites

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1

    Brescia, Lombardy, 25123

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia

    Rome, Lazio, 00189

  • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia

    Treviso, Veneto, 31100

Other trials in Italy

Poland4 sites

  • NZOZ Kendron

    Bialystok, 15-402

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Centra Medyczne Medyceusz

    Lodz, 91-053

  • Centrum Medycznym Gamma

    Warsaw, 01-785

Other trials in Poland

Hungary3 sites

  • Debreceni Egyetem Klinikai Kozpont - Onkologiai Klinika

    Debrecen, 4032

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7625

  • Trial Pharma Kft. Szeged

    Szeged, 6726

Other trials in Hungary

United Kingdom3 sites

  • Cardiff and Vale University Health Board |University Hospital of Wales - Clinical Research Facility

    Cardiff, Wales, CF14 4XW

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF

  • Nottingham University Hospital

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

South Korea2 sites

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Ajou University Hospital | Radiology

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Sweden2 sites

  • Karolinska Universitetssjukhuset - Huddinge - Radiologi

    Stockholm, Stockholm County, 141 86

  • Akademiska sjukhuset i Uppsala

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Canada1 site

  • Hôpital du Sacré-Cœur de Montréal | Radiology

    Montreal, Quebec, H4J 1C5

Other trials in Canada

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 Any Body Region (Except 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 any known or suspected problems (except 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 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 known or suspected problems (except brain or spinal cord-related problems) with 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 groups in NCT05915728
Study groupRoleWhat they receive
Gadoquatrane - Approved Macrocyclic GBCAExperimentalParticipants will receive one intravenous injection of gadoquatrane during MRI in Period 1, followed by one intravenous injection of any approved macrocyclic GBCA during MRI in Period 2.
Receives: Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol; Drug: Gadoterate meglumine; Drug: Gadoteridol
Approved Macrocyclic GBCA - GadoquatraneExperimentalParticipants will receive one intravenous injection of any approved macrocyclic GBCA during MRI in Period 1, followed by one intravenous injection of gadoquatrane 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.

  1. Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR

    Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

    Measured: 1 day procedure

  2. Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR

    Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

    Measured: 1 day procedure

  3. Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR

    Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging

    Measured: 1 day procedure

Secondary outcomes (14)

  1. Visualization Parameter Contrast Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR

    Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents

    Measured: Two MRI examinations with an interval of 3-14 days between them

  2. Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR

    Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents

    Measured: Two MRI examinations with an interval of 3-14 days between them

  3. Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR

    Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents

    Measured: Two MRI examinations with an interval of 3-14 days between them

  4. 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. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  5. 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. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  6. The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs

    Overall diagnostic clinical value is based on the three descriptive imaging features; enhancement location, extension and pattern and is measured on a 5 point scale: 1- no diagnostic clinical value; 2-poor diagnostic clinical value; 3- moderate diagnostic clinical value; 4- good diagnostic clinical value; 5-excellent diagnostic clinical value. BICR = Blinded independent central reviewer.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  7. 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 (cSoT), and sensitivity with corresponding 95% confidence intervals was calculated.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  8. 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 (cSoT), and specificity with corresponding 95% confidence intervals was calculated.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  9. 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 in the image set, was asked for the diagnosis based on the combined pre- and post-contrast MRI image sets for each period, which was compared to the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician. 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: Two MRI examinations with an interval of 3-14 days between them

  10. Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator

    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: Two MRI examinations with an interval of 3-14 days between them

  11. Number of Lesions Seen on Unenhanced MR Image Sets and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR

    Total number of lesions across all participants was counted by 3 blinded independent central readers on the unenhanced (pre-contrast) and combined pre- and post-contrast gadoquatrane and comparator MR image set.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  12. 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

    The total number of contrast-enhanced lesions for each contrast- enhanced image set (gadoquatrane and comparators-enhanced MR images) was evaluated by two of the blinded independent central readers.

    Measured: Two MRI examinations with an interval of 3-14 days between them

  13. 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 (TEAEs), including serious adverse events (TESAEs), 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

  14. Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious 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.

  1. First posted23 Jun 2023
  2. Study start24 Jul 2023
  3. Primary completion31 May 2024
  4. Study completion1 Jun 2024

Resources

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
Model description
The site staff in charge of the preparation and administration of study intervention will be unblinded and will not be involved in any evaluation of safety and efficacy. The site staff in charge of conducting all other study procedures as per the schedule of activities (SoA) will remain blinded to the study intervention administered.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915728
Sponsor's protocol ID
21197
Other IDs
2022-501885-24-00
Acronym
Quanti OBR
Status last verified
Jun 2026
First submitted
14 Jun 2023
Last updated
20 Aug 2026
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gadoquatrane (BAY1747846), Gadobutrol and Gadoterate meglumine in people with Contrast Enhancement in Magnetic Resonance Imaging and Non-central Nervous System Pathology, run by Bayer at 85 sites in 16 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 4 inclusion and 10 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in Japan, United States, China, Bulgaria, Argentina and 11 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 20 Aug 2026). 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?

Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR (time frame: 1 day procedure). The study lists 3 primary outcomes in all. 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 NCT05915728.

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 20 Aug 2026.

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