Clinical Trials
Numerous clinical trials spanning Phase 1 through Phase 4 evaluate gadobutrol, a non-ionic macrocyclic gadolinium-based contrast agent for magnetic resonance imaging, across conditions including central nervous system lesions, carotid stenosis, brain and spinal cord diseases, and secondary cardiomyopathies. Sponsored by pharmaceutical corporations such as Bayer and GE Healthcare, academic institutions, and medical technology entities like Subtle Medical, the portfolio includes completed, actively recruiting, enrolled by invitation, and terminated protocols. These studies systematically evaluate the diagnostic efficacy, safety, and optimized dosage regimens of gadobutrol across diverse clinical imaging applications.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04373564 | RECRUITING | Motor Function; Cognitive Function; Contrast Media |
Guerbet |
2021-03-24 | PHASE4 |
| NCT02156739 | ACTIVE_NOT_RECRUITING | Hepatocellular Carcinoma; Liver and Intrahepatic Bile Duct Disorder; Metastatic Malignant Neoplasm in the Liver; Primary Malignant Liver Neoplasm |
M.D. Anderson Cancer Center |
2014-10-13 | |
| NCT07796360 | NOT_YET_RECRUITING | Healthy Volunteers |
National Institute of Neurological Disorders and Stroke (NINDS) |
2026-09-14 | PHASE1 |
| NCT04369560 | RECRUITING | Urinary Bladder Neoplasms |
Jodi Maranchie |
2025-05-23 | EARLY_PHASE1 |
| NCT07472491 | RECRUITING | Known or Highly Suspected Central Nervous System (CNS) Lesion; Known or Highly Suspected Body (Excluding CNS) Lesion |
GE Healthcare |
2026-04-01 | PHASE2; PHASE3 |
| NCT04219904 | ACTIVE_NOT_RECRUITING | Stage IA Cervical Cancer; Stage IA1 Cervical Cancer; Stage IA2 Cervical Cancer; Stage IB Cervical Cancer; Stage IB1 Cervical Cancer; Stage IB2 Cervical Cancer; Stage IB3 Cervical Cancer |
M.D. Anderson Cancer Center |
2018-09-07 | EARLY_PHASE1 |
| NCT07040865 | RECRUITING | Suspect Renal and Adrenal Imaging Findings |
Insel Gruppe AG, University Hospital Bern |
2025-08-18 | PHASE4 |
| NCT04893434 | ACTIVE_NOT_RECRUITING | Gynecologic Cancer |
Memorial Sloan Kettering Cancer Center |
2021-05-13 | PHASE1 |
| NCT06846853 | RECRUITING | Contrast Enhanced Images vs. Non-contrast Images; Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images |
UConn Health |
2025-03-25 | PHASE4 |
| NCT04910425 | WITHDRAWN | Prostate Carcinoma |
Northwestern University |
2023-06-17 | PHASE2 |
| NCT07275814 | COMPLETED | For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions |
Shanghai Shengdi Pharmaceutical Co., Ltd |
2025-11-17 | PHASE3 |
| NCT07275723 | COMPLETED | For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Abnormal Vascular Lesions in Body Regions Excluding the Central Nervous System (CNS) |
Shanghai Shengdi Pharmaceutical Co., Ltd |
2025-11-14 | PHASE3 |
| NCT03730051 | COMPLETED | Breast Diseases |
University of Massachusetts, Worcester |
2021-03-01 | PHASE4 |
| NCT06224543 | COMPLETED | Enhancing Brain Lesions |
Subtle Medical |
2023-06-16 | PHASE1 |
| NCT06010173 | COMPLETED | Lesion in Body Region; CNS Lesion |
Guerbet |
2023-07-21 | PHASE3 |
| NCT05762367 | COMPLETED | Idiopathic Intracranial Hypertension |
Institut National de la Santé Et de la Recherche Médicale, France |
2023-03-10 | |
| NCT06731829 | NOT_YET_RECRUITING | For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions |
Jiangsu HengRui Medicine Co., Ltd. |
2024-12 | PHASE2 |
| NCT05915728 | COMPLETED | Contrast Enhancement in Magnetic Resonance Imaging; Non-central Nervous System Pathology |
Bayer |
2023-07-24 | PHASE3 |
| NCT05915702 | COMPLETED | Contrast Enhancement in Magnetic Resonance Imaging; Central Nervous System Pathology |
Bayer |
2023-07-24 | PHASE3 |
| NCT06224543 | Enrolling by invitation | Enhancing Brain Lesions |
Subtle Medical |
2023-06-16 | Phase 1 |
| NCT04949321 | UNKNOWN | Inner Ear ; Meniere's Disease; Imaging |
University Hospital, Grenoble |
2021-07-31 | |
| NCT05350189 | Completed | Contrast Enhancement in Magnetic Resonance Imaging |
Bayer |
2022-11-03 | -- |
| NCT04307186 | COMPLETED | Central Nervous System Pathology |
Bayer |
2020-11-18 | PHASE2 |
| NCT04132843 | COMPLETED | Brain Neoplasm; Lymphoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Malignant Brain Neoplasm |
M.D. Anderson Cancer Center |
2020-01-10 | |
| NCT03986138 | COMPLETED | Lesion in Body Region |
Guerbet |
2019-08-27 | PHASE3 |
| NCT03996447 | COMPLETED | CNS Lesion; Blood Brain Barrier Defect |
Guerbet |
2019-06-03 | PHASE3 |
| NCT04350957 | WITHDRAWN | Breast Cancer |
University of Chicago |
2020-08-24 | |
| NCT03602339 | COMPLETED | Magnetic Resonance Imaging |
Bayer |
2018-11-14 | PHASE4 |
| NCT03404648 | COMPLETED | Prostate Adenocarcinoma |
Mayo Clinic |
2017-11-01 | PHASE3 |
| NCT02796729 | TERMINATED | Brain Neoplasms, Malignant; Metastasis |
British Columbia Cancer Agency |
2016-10 | PHASE2 |
| NCT01989000 | COMPLETED | Pancreatic Cancer |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2013-11 | |
| NCT00375830 | COMPLETED | Cancer |
Stanford University |
2006-01 | PHASE2 |
| NCT02135861 | COMPLETED | Heart Failure, Congestive |
GlaxoSmithKline |
2014-07-30 | PHASE1 |
| NCT01995240 | COMPLETED | Pancreatic Cancer |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2013-04 | |
| NCT02350426 | TERMINATED | Arthritis, Rheumatoid |
GlaxoSmithKline |
2015-08-12 | PHASE1 |
| NCT01890434 | COMPLETED | Coronary Artery Disease |
Bayer |
2013-08-26 | PHASE3 |
| NCT01890421 | COMPLETED | Coronary Artery Disease |
Bayer |
2013-07-19 | PHASE3 |
| NCT02274246 | COMPLETED | Left Atrial Fibrosis |
Fundacion Clinic per a la Recerca Biomédica |
2014-11 | PHASE1 |
| NCT00828737 | COMPLETED | Fibrosis; Renal Impairment |
Bayer |
2008-12 | PHASE4 |
| NCT02967380 | TERMINATED | Adult Anaplastic (Malignant) Meningioma; Adult Anaplastic Astrocytoma; Adult Anaplastic Ependymoma; Adult Anaplastic Oligodendroglioma; Adult Brain Stem Glioma; Adult Choroid Plexus Neoplasm; Adult Diffuse Astrocytoma; Adult Ependymoblastoma; Adult Ependymoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Grade II Meningioma; Adult Medulloblastoma; Adult Mixed Glioma; Adult Oligodendroglioma; Adult Papillary Meningioma; Adult Pineal Gland Astrocytoma; Adult Pineoblastoma; Adult Primary Melanocytic Lesion of Meninges; Adult Supratentorial Primitive Neuroectodermal Tumor; Malignant Adult Intracranial Hemangiopericytoma; Metastatic Malignant Neoplasm in the Brain; Multiple Sclerosis; Recurrent Adult Brain Neoplasm |
University of Southern California |
2011-12-14 | |
| NCT01344447 | COMPLETED | Carotid Stenosis |
Bayer |
2011-05-12 | PHASE3 |
| NCT01613417 | COMPLETED | Brain Disease |
Bracco Diagnostics, Inc |
2012-08 | PHASE4 |
| NCT01544166 | COMPLETED | Magnetic Resonance Imaging |
Bayer |
2012-05-16 | PHASE1 |
| NCT01660841 | COMPLETED | Magnetic Resonance Imaging |
Bayer |
2012-09 | PHASE3 |
| NCT01655290 | COMPLETED | Subacute/Chronic Myocardial Infarction |
Technical University of Munich |
2012-08 | PHASE2 |
| NCT01344460 | COMPLETED | Renal Artery Obstruction |
Bayer |
2011-05 | PHASE3 |
| NCT01104584 | COMPLETED | Breast Cancer |
Bayer |
2010-05 | PHASE3 |
| NCT01067976 | COMPLETED | Breast Cancer; Diagnostic Imaging |
Bayer |
2010-02 | PHASE3 |
| NCT01050829 | COMPLETED | Magnetic Resonance Imaging |
Bayer |
2010-01 | PHASE3 |
| NCT00764387 | COMPLETED | Neoplastic CNS Lesions |
Bayer |
2008-03 | PHASE4 |
| NCT00709852 | COMPLETED | Diagnostic Imaging; Central Nervous System Diseases |
Bayer |
2008-06 | PHASE3 |
| NCT00623467 | COMPLETED | Central Nervous System Diseases |
Bayer |
2007-12 | PHASE3 |
| NCT00549861 | COMPLETED | Cardiomyopathy, Dilated; Cardiomyopathies, Secondary |
Oliver Strohm |
2007-09 | |
| NCT00522951 | COMPLETED | Brain Metastases |
Bayer |
2007-08 | PHASE3 |
| NCT00468819 | COMPLETED | Magnetic Resonance Imaging |
Bayer |
2007-05 | PHASE1 |
| NCT00395733 | COMPLETED | Vascular Diseases |
Bayer |
2006-10 | PHASE3 |
| NCT00395460 | COMPLETED | Central Nervous System Diseases |
Bayer |
2006-09 | PHASE3 |
| NCT00862459 | COMPLETED | Brain Diseases; Spinal Cord Diseases |
Bayer |
2005-08 | PHASE2 |
| NCT01490294 | COMPLETED | Myocardial Perfusion Imaging; Magnetic Resonance Imaging |
Bayer |
2004-03 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-01-22)
Check the
Gadobutrol
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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Note: Technical data last updated: Sep 1, 2026.