Gadodiamide Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate gadodiamide-related diagnostic and safety outcomes across conditions such as chronic kidney disease, gadolinium deposition disease, benign prostatic hyperplasia, and autism spectrum disorder. Comprising Phase 4 post-marketing safety trials as well as observational and interventional studies, sponsor types include industry entities like GE Healthcare and academic institutions such as Stanford University, Children's Hospital of Fudan University, and Cornell University. Recruitment status ranges from completed safety assessments in renal-impaired populations to upcoming evaluations of chelation therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06269055	Not yet recruiting	Gadolinium Deposition Disease\|Ca-DTPA	Stanford University	2024-05-15	--
NCT04511767	Completed	Autism Spectrum Disorder\|Global Developmental Delay\|Language Disorder	Children''s Hospital of Fudan University	2019-09-01	--
NCT00908310	Completed	Chronic Kidney Disease\|Renal Insufficiency	GE Healthcare\|i3 Statprobe	2009-05	Phase 4
NCT00364585	Completed	Benign Prostatic Hyperplasia	Weill Medical College of Cornell University	2006-05	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gadodiamide acts as a non-ionic paramagnetic contrast agent by complexing gadolinium ions (Gd3+), which alters local magnetic susceptibility and significantly shortens the T1 relaxation time of surrounding water hydrogen nuclei under an applied magnetic field. This accelerated proton relaxation increases localized signal intensity on T1-weighted images, providing enhanced anatomical resolution during magnetic resonance imaging to support diagnostic evaluations and safety assessments in conditions such as renal insufficiency or gadolinium deposition disease.

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>).