Delving into the Latest Updates on Isosulfan Blue with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Other diagnostic agent

Synonyms

Isosulfan blue (USAN), Isosulfan blue inner salt, 异舒泛蓝

+ [5]

Target-

Mechanism

Diagnostic dye

Therapeutic Areas

Hemic and Lymphatic DiseasesOther Diseases

Active Indication-

Inactive Indication

Diagnostic agentsLymphedema

Originator Organization

Covidien Unlimited Co.

Active Organization-

Inactive Organization

Covidien Unlimited Co.

Drug Highest PhaseWithdrawn

First Approval Date

US (29 Jul 1981),

Diagnostic agentsLymphedema

Regulation-

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Structure

Molecular FormulaC27H32N2NaO6S2

InChIKeyAVZOEHZTSPLXBS-UHFFFAOYSA-N

CAS Registry68238-36-8

The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov Imaging Platform, to perform sentinel lymph node biopsy.
Participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. Active participation will last through the post-operative visit.

Start Date13 Apr 2023

Sponsor / Collaborator

University of Wisconsin Madison

[+2]

CTR20210602 / CompletedNot Applicable

一项多中心、单臂、开放性设计的验证性临床研究评价异硫蓝注射液用于早期乳腺癌患者前哨淋巴结示踪的有效性和安全性

[Translation] A multicenter, single-arm, open-label confirmatory clinical study to evaluate the efficacy and safety of isosulfan blue injection for sentinel lymph node tracing in patients with early breast cancer

主要目的：评价异硫蓝注射液用于早期乳腺癌患者前哨淋巴结示踪的有效性次要目的：评价异硫蓝注射液用于早期乳腺癌患者前哨淋巴结示踪的安全性

[Translation]

Primary objective: To evaluate the effectiveness of isosulfan blue injection for sentinel lymph node tracing in patients with early breast cancer Secondary objective: To evaluate the safety of isosulfan blue injection for sentinel lymph node tracing in patients with early breast cancer

Start Date23 May 2021

Sponsor / Collaborator

Guangdong Hebo Pharmaceutical Co Ltd.

[+1]

NCT03927027 / Active, not recruitingPhase 3IIT

ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Start Date29 Jul 2019

Sponsor / Collaborator

Alliance Foundation Trials LLC

[+1]

100 Clinical Results associated with Isosulfan Blue

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100 Translational Medicine associated with Isosulfan Blue

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100 Patents (Medical) associated with Isosulfan Blue

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174

Literatures (Medical) associated with Isosulfan Blue

01 Jul 2024·Asian Journal of Surgery

The feasibility and added value of indocyanine green tracing in guiding sentinel lymph node biopsy for breast cancer

Article

Author: Senol, Kazim ; Polatkan, Volkan ; Gurluler, Ercument ; Gokgoz, Mustafa Sehsuvar

OBJECTIVETo compare the effectiveness of combined (indocyanine green [ICG]+ blue dye) tracing versus blue dye alone in guiding sentinel lymph node biopsy (SLNB) in breast cancer.METHODSA total of 112 female patients (mean ± SD age: 51.9 ± 11.9 years) with clinically node-negative (cN0) early-stage breast cancer were evaluated based on SLN tracing technique including methylene blue + ICG (n = 17), isosulfan blue + ICG (n = 19) and methylene blue alone (n = 76). Mapping patterns of each SLN, the number of total lymph nodes (TLNs) removed, including metastatic and hyperplastic lymph nodes, and the metastatic lymph node detection rate were analyzed for each tracing technique.RESULTSSLN detection rate was 100 % with complementary use of ICG. No significant difference was noted between methylene blue + ICG, isosulfan + ICG and methylene blue alone groups in terms of the mean ± SD number of TLNs removed (3.9 ± 2.5, 4.7 ± 3 and 3.7 ± 2.3, respectively) and metastatic lymph node detection rates (16.0 %, 16.25 % and 13.98 %, respectively). Complementary use of ICG revealed the N0 stage for 66.6 % of cases considered as Nx (cannot be detected) on blue dye alone. Also, 20.0 % of N0 and 11.1 % of N1 cases on blue dye were diagnosed with more advance nodal status (N1 and N2 respectively) after complementary use of ICG.CONCLUSIONSThe combined tracing (ICG + blue dye) seems valuable not only in terms of the SLN detection rates and lymph node yield but also has an added value in providing more accurate nodal stating and thus a proper final tumor staging with considerable therapeutic implications.

01 Mar 2024·European Journal of Clinical Investigation

Sentinel lymph node biopsy for breast cancer during pregnancy: A comprehensive update

Review

Author: Margioula-Siarkou, Chrysoula ; Zervoudis, Stefanos ; Sotiriadis, Alexandros ; Dinas, Konstantinos ; Petousis, Stamatios ; Amant, Fréderic ; Margioula-Siarkou, Georgia ; Bothou, Αnastasia

AbstractBackgroundPregnant patients diagnosed with breast cancer (PrBC) may receive substantially different treatments compared to general population, considering that certain treatment options cannot be applied during pregnancy due to their potential harmful effects to the foetus. Regarding the use of sentinel lymph node biopsy (SLNB) in pregnant patients, potential concerns include foetal harm from radiation exposure, possible teratogenic effects of blue dyes and maternal anaphylaxis to isosulfan.ObjectiveThe main objective of the present systematic review is to summarize and present current knowledge and up‐to‐date evidence about the safety and efficacy of SLNB in PABC.MethodsMEDLINE, Google Scholar and UpToDate databases were searched up to 22 January 2023. Articles studying the safety and effectiveness of SLNB in patients for PrBC were eligible for inclusion in the present review.ResultsIn total, 63 articles that met the inclusion criteria were included in this study. Forty‐seven articles were strongly in favour of performing SLNB in PABC, 4 articles were partially in favour, 10 articles were strongly against and 2 articles were partially against performing SLNB in PABC. Sub‐categorization based on type of study showed that the majority of studies in favour were of higher level of evidence than those against. Furthermore, there were overall 12 studies reporting on outcomes. There were overall 382 women with PrBC that underwent SLNB. Full data were reported for 237 cases. Overall live birth rate was 95.8%, while overall neonatal complication rate was 3.4%.No case of maternal side effects or anaphylactic reaction, maternal death, stillbirth and neonatal death was reported (0%).ConclusionsSentinel lymph node biopsy seems to be safe and effective technique for breast cancer during pregnancy.

01 Jan 2024·The American Journal of Surgery

Evaluation of learning curve with Indocyanine Green (IcG) versus blue dye for sentinel lymph node biopsy in breast cancer

Article

Author: Kilgore, Lyndsey J ; Pruitt, Peggy ; Larson, Kelsey E ; Baker, Jordan ; Chollet-Hinton, Lynn ; Hounschell, Corey A ; Wagner, Jamie L ; Balanoff, Christa R ; Wilder, Chloe

BACKGROUNDIndocyanine green (IcG) is an alternative to isosulfan blue (IB) for sentinel lymph node (SLN) mapping in breast cancer (BC). IcG carries improved cost and safety, but oncologic data upon implementation in practice is limited. We evaluated the learning curve defined as oncologic yield and operative (OR) time for IcG in SLN mapping in BC.METHODSRetrospective review of patients >18 years with cTis-2 cN0 BC undergoing surgery first with SLN biopsy using IB or IcG. Analysis compared IB versus IcG across three time cohorts.RESULTSOf 278 patients, 77 received IB and 201 received IcG. OR time was longer for IcG (p = 0.022). There was no difference in oncologic yield between groups (p = 0.35, p = 0.61).CONCLUSIONSSurgeons may be able to safely transition from IB to IcG for patients with early-stage breast cancer undergoing surgery first. Individuals should track their own data to confirm safety of the technique.

100 Deals associated with Isosulfan Blue

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External Link

KEGG	Wiki	ATC	Drug Bank
D04634	-	V04CX	DB09136

R&D Status

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05859971 (CTgov)	Early Phase 1	Breast Cancer	10	SLN mapping+isosulfan blue+technetium-99m	aaizaizfmk(rfipftaeck) = pmjfskezrd ndouaqkfil (sknvaijkxb, bsvsyknezr - mxcohljsuw) View more	-	15 Aug 2024
NCT02509598 (CTgov)	Phase 2	Rhabdomyosarcoma \| Melanoma	24	Lymph Node Mapping+Vital Blue Dye (optional)+Tc99m tilmanocept	qtbapqonbo(yjjwylgdot) = jlpssnsbth yvsvzkxwqq (dqciykgouo, bzemnmrucg - xigwbtqdtk) View more	-	28 Jun 2024
NCT01818739 (CTgov)	Not Applicable	Endometrial Carcinoma	204	sentinel lymph node detection+isosulfan blue	fhfuitkmme(wrydpzbaoh) = xpaddfbrxu phxybxljox (jyscbfwvcj, gchvtsvkhi - mnikzmkhxy) View more	-	22 Jun 2021
NCT02336737 (SentiMagIC, CTgov)	Not Applicable	Breast Cancer	160	SiennaXP+Technetium Tc99m Sulfur Colloid+Isosulfan blue dye	wlxmerhvio(bodwtsoguh) = gurgqpqbof lrqxvnghfo (ubljltnkde, spnusqruis - kqiduyrjre) View more	-	03 Nov 2020
NCT01939028 (CTgov)	Not Applicable	Metastatic endometrial cancer	58	lymphadenectomy+isosulfan blue	uwajirljyr(bawqtaendl) = syzubyvcyk rzjsyzuwzn (yqwjslqhxb, kummclvoum - ucprgyumzk) View more	-	17 Aug 2020
ASCO2018	Not Applicable	Solid tumor \| Breast Cancer \| Melanoma	1,163	Isosulfan blue	jzaxfjgzbf(qgqzuqqrsr) = Of all patients with a history of asthma, 0.71% (1/141) had a likely allergic reaction, manifested as a rash. gwhslbtwib (eamihydbjk ) View more	Positive	01 Jun 2018
NCT01771666 (CTgov)	Phase 2	Breast Cancer	23	Isosulfan+Indocyanine green	otkuaqrygn(vyiztatdhf) = olyzwatpxv fozrdsofbn (rtfqeaivbv, gjjxcyjplx - tpniuvtuaj) View more	-	11 Dec 2017
NCT00070317 (CTgov)	Not Applicable	Adenosquamous Carcinoma \| Cervical Squamous Cell Carcinoma \| Uterine Cervix Adenocarcinoma	102	Sentinel Lymph Node Biopsy+Methylene Blue+Isosulfan Blue	sqzwqvxqai(dlkvkwcdfw) = acvtkwnoet ntiomgbjxj (siecbwkfur, hehpmjxvhj - rutnftfenv) View more	-	03 Oct 2017
NCT00932035 (CTgov)	Phase 1/2	Breast Cancer \| Lymphedema	39	axillary lymph node dissection+isosulfan blue based lymphatic mapping (Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection))	sujttuakyq(lbjinzoqtp): P-Value = 0.45 View more	-	07 Jun 2017
NCT00932035 (CTgov)	Phase 1/2	Breast Cancer \| Lymphedema	39	axillary lymph node dissection+isosulfan blue based lymphatic mapping (Arm II (Control))	sujttuakyq(lbjinzoqtp): P-Value = 0.45 View more	-	07 Jun 2017
ASCO2015	Not Applicable	Early Stage Breast Carcinoma	-	Lymphazurin	xryvjhamms(ltsnqmlhbf) = 2 pts with anaphylaxis gzokoxfqht (nsefnbvvpp ) View more	-	20 May 2015
ASCO2015	Not Applicable	Early Stage Breast Carcinoma	-	1% lymphazurin (Methylene blue)		-	20 May 2015