Clinical Trials

Gadoteridol has been evaluated across multiple clinical trials spanning early-stage through post-marketing phases to assess magnetic resonance imaging contrast enhancement for central nervous system, non-central nervous system, and metastatic conditions. Sponsored by major industry entities and academic institutions, several clinical trials investigate both diagnostic efficacy and safety parameters, such as post-administration motor and cognitive functions. These research efforts encompass diverse recruitment statuses, including both completed and actively recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04373564 RECRUITING
Motor Function; Cognitive Function; Contrast Media
Guerbet
 2021-03-24 PHASE4
NCT04248543 COMPLETED
Spinal Metastases
Duke University
 2020-12-22
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
NCT05357833 COMPLETED
Secondary Progressive Multiple Sclerosis; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis
University of Utah
 2022-06-01 EARLY_PHASE1
NCT04608812 TERMINATED
Glioma, Malignant; High Grade Glioma; Glioblastoma; Glioblastoma Multiforme; Anaplastic Astrocytoma
OncoSynergy, Inc.
 2021-03-02 PHASE1
NCT02359097 COMPLETED
Glioblastoma
OHSU Knight Cancer Institute
 2015-01-06
NCT02481882 UNKNOWN
Multiple Sclerosis
University of Nottingham
 2017-01
NCT03750188 Completed
Central Nervous System Diseases|Central Nervous System Neoplasms
Bracco Diagnostics Inc
 2018-11-01 --
NCT01613417 COMPLETED
Brain Disease
Bracco Diagnostics, Inc
 2012-08 PHASE4
NCT00709852 COMPLETED
Diagnostic Imaging; Central Nervous System Diseases
Bayer
 2008-06 PHASE3
NCT00522951 COMPLETED
Brain Metastases
Bayer
 2007-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-01-22)

Check the Gadoteridol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a nonionic macrocyclic gadolinium complex, gadoteridol alters the nuclear relaxation rates of surrounding water protons to markedly shorten longitudinal relaxation times within targeted tissues. This biophysical effect enhances signal intensity on T1-weighted magnetic resonance imaging, facilitating high-contrast visualization of structural abnormalities in clinical conditions such as central nervous system neoplasms, brain metastases, and multiple sclerosis.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.