Isosulfan Blue Clinical Trials

Size	Price	Qty
5mg	USD 137
25mg	USD 417

Clinical Trials

Isosulfan blue has been investigated in numerous clinical trials evaluating its utility as a diagnostic dye for intraoperative lymphatic mapping and sentinel lymph node detection. Clinical investigations encompass a broad range of oncological conditions, including breast cancer, endometrial carcinoma, cervical cancer, colorectal cancer, head and neck cancer, and recurrent melanoma. These studies span Early Phase I through Phase III evaluations sponsored by academic institutions, research consortia, and medical technology companies such as the Gynecologic Oncology Group, Ohio State University Comprehensive Cancer Center, and Stanford University. Protocol recruitment statuses across these studies include completed, active not recruiting, and terminated, with several trials comparing isosulfan blue to alternative fluorescence imaging agents like indocyanine green.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03927027	ACTIVE_NOT_RECRUITING	Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III	Alliance for Clinical Trials in Oncology	2019-07-29	PHASE3
NCT07269860	COMPLETED	Breast Cancer	University of Arizona	2025-07-09
NCT05663112	COMPLETED	Sentinel Lymph Node; Breast Cancer	Manisa Celal Bayar University	2021-12-06
NCT05859971	COMPLETED	Breast Cancer	University of Wisconsin, Madison	2023-04-13	EARLY_PHASE1
NCT01818739	COMPLETED	Endometrial Cancer	Ohio State University Comprehensive Cancer Center	2013-03
NCT01939028	TERMINATED	Stage I Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage III Endometrial Carcinoma; Stage IV Endometrial Carcinoma	Case Comprehensive Cancer Center	2013-07
NCT02336737	COMPLETED	Breast Cancer	Endomagnetics Inc	2015-01
NCT02368067	UNKNOWN	Endometrial Carcinoma	Southeastern Regional Medical Center	2014-06
NCT01771666	COMPLETED	Breast Cancer	Stanford University	2012-07	PHASE2
NCT02068820	COMPLETED	Endometrial Cancer	AdventHealth	2012-09
NCT01038908	UNKNOWN	Breast Cancer	University of British Columbia	2013-06	PHASE2
NCT01898403	COMPLETED	Recurrent Melanoma	Stanford University	2013-06
NCT00932035	TERMINATED	Breast Cancer	City of Hope Medical Center	2009-06	PHASE1; PHASE2
NCT00070317	TERMINATED	Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Stage I Cervical Cancer	Gynecologic Oncology Group	2004-06
NCT00450723	COMPLETED	Breast Cancer	University of Miami	2004-05
NCT00717886	COMPLETED	Breast Cancer; Axillary Lymph Node Dissection	Memorial Sloan Kettering Cancer Center	2008-06
NCT00625625	UNKNOWN	Colorectal Cancer	Saint John's Cancer Institute	2004-03	PHASE2
NCT00438477	COMPLETED	Breast Cancer	M.D. Anderson Cancer Center	2005-06
NCT00003186	COMPLETED	Colorectal Cancer; Metastatic Cancer	Roswell Park Cancer Institute	1997-04
NCT00012168	COMPLETED	Head and Neck Cancer	NYU Langone Health	1999-05

(data from https://clinicaltrials.gov, updated on 2026-04-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following interstitial administration, isosulfan blue selectively binds to serum proteins such as albumin and drains into interstitial lymphatic vessels, accumulating in regional lymph nodes. This localized lymphatic uptake provides direct visual delineation of nodal anatomy, facilitating accurate intraoperative sentinel lymph node mapping in patients with breast cancer, endometrial cancer, cervical cancer, and colorectal cancer.

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>).