Delving into the Latest Updates on Technetium Tc-99M Sulfur Colloid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Diagnostic radiopharmaceuticals

Synonyms

Technetium Tc-99M Sulfur Colloid Kit, 锝[99mTc]硫化胶体, An-Sulfur Colloid

+ [3]

Target-

Action

enhancers

Mechanism

PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsDigestive System DisordersMouth and Tooth Diseases+ [2]

Active Indication

MelanomaBreast CancerGastroesophageal Reflux+ [1]

Inactive Indication

Diagnostic agents

Originator Organization

GE Healthcare, Inc.

Active Organization

HTA Co., Ltd.

Sun Pharmaceutical Industries, Inc.

Inactive Organization

Mallinckrodt, Inc.(Old)

GE Healthcare, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (24 Sep 1974),

Diagnostic agents

Regulation-

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Structure/Sequence

Molecular FormulaS8Tc

InChIKeyFJTPHHNWVXNMEK-IEOVAKBOSA-N

CAS Registry-

主要目的：评价锝[99mTc]硫化胶体注射液在乳腺癌患者中进行前哨淋巴结示踪的有效性；次要目的：评价锝[99mTc]硫化胶体注射液在乳腺癌患者中进行前哨淋巴结示踪的安全性；探索性目的：探索锝[99mTc]硫化胶体注射液注射前预处理时间对检出率的影响；探索手持伽马计数器对前哨淋巴结闪烁记数阳性阈值的合理性。

[Translation]

Primary purpose: To evaluate the effectiveness of technetium [99mTc] sulfide colloid injection in sentinel lymph node tracing in breast cancer patients; Secondary purpose: To evaluate the safety of technetium [99mTc] sulfide colloid injection in sentinel lymph node tracing in breast cancer patients; Exploratory purpose: To explore the effect of pretreatment time before technetium [99mTc] sulfide colloid injection on the detection rate; To explore the rationality of the positive threshold of sentinel lymph node scintigraphy by handheld gamma counter.

Start Date02 Jan 2024

Sponsor / Collaborator

HTA Co., Ltd.

NCT03029988

/ TerminatedPhase 1

An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to Fluorodeoxyglucose (FDG) PET/CT Imaging.

Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.

Start Date26 Jul 2017

Sponsor / Collaborator

Navidea Biopharmaceuticals, Inc.

[+2]

NCT02881554

/ TerminatedNot ApplicableIIT

Functional Liver Imaging With Sulfur Colloid SPECT/CT in Primary and Metastatic Liver Cancer Patients Receiving Liver-Directed Treatment: A Pilot Study

This pilot trial studies how well single photon emission computed tomography (SPECT)/computed tomography (CT) with technetium Tc-99m sulfur colloid works in measuring liver function in patients with liver cancer that has or has not spread to other place in the body who are undergoing radiation therapy or surgery. Diagnostic procedures, such as sulfur colloid SPECT/CT scans, may measure normal liver tissue before, during and after treatment and help doctors plan better treatment for liver cancer patients.

Start Date21 Dec 2016

Sponsor / Collaborator

University of Washington

100 Clinical Results associated with Technetium Tc-99M Sulfur Colloid

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100 Translational Medicine associated with Technetium Tc-99M Sulfur Colloid

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100 Patents (Medical) associated with Technetium Tc-99M Sulfur Colloid

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39

Literatures (Medical) associated with Technetium Tc-99M Sulfur Colloid

01 Nov 2020·Malaysian orthopaedic journal

Combined Techniques of Non-invasive 99mTcBesilesomab/ 99mTc-Sulfur Colloid with Hybrid SPECT/CT Imaging in Characterising Cellulitis from Symptomatic Perimegaprosthetic Infection: A Case Report

Author: Faisham, W I ; Wan-Sohaimi, W F ; Mohd-Rohani, M F ; Nawi, N M ; Tagiling, N

Megaprosthesis is used to restore the form and function of massive skeletal defects, but it is accompanied by risks of failure, mainly due to perimegaprosthetic infection (PMI). In practice, the diagnosis of infected megaprosthesis among patients with a high index of clinical suspicion, elevated serological markers, and multiple negative or inconclusive imaging can be very challenging and poses a diagnostic conundrum to many orthopaedic surgeons. We present the case of a symptomatic 26-year-old female with large B-cell lymphoma who developed cellulitis with suspected complication of PMI 15 months post-implantation. The combination of advanced nuclear medicine imaging strategies, i.e., ^99mTc-besilesomab/^99mTc-sulfur colloid scintigraphy with hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) scanning helps to characterise and delineate both infections. Invasive procedures such as joint aspiration and biopsy were avoided, and the patient was successfully treated with antibiotics. Hence, we report a case where advanced imaging modalities were decisive in the investigation of PMI.

01 Mar 2018·Journal of medical imaging and radiation sciences

Effect of Topical Anesthetic Cream on Pain During Periareolar Injection of Technetium Tc99m Sulfur Colloid for Sentinel Lymph Node Biopsy in Breast Cancer: A Randomized Control Trial

Article

Author: Suryavanshi, Rajeev ; Canning, Sarah ; Bryson-Campbell, Mikelle

BACKGROUND:

Injection of Tc99m to localize nodes for sentinel lymph node biopsy is reported by patients as very painful. The purpose of this study was to determine if anesthetic cream reduces pain associated with periareolar injection of Tc99m and to help elucidate conflicting literature regarding the efficacy of anesthetic cream for this procedure.

METHODS:

A randomized, double-blind, placebo-controlled methodology was used for adult females with breast cancer undergoing periareolar injection of Tc99m for sentinel lymph node biopsy. Pain levels were compared using anesthetic cream (2.5% lidocaine/2.5% prilocaine) vs. placebo. Patient exclusion criteria included use of opioids or adjuvant pain medication or injecting Tc99m the day before surgery. The Numerical Rating Scale was used to assess pain levels immediately after the injections.

RESULTS:

Comparing 23 experimental and 26 control patients, there was no significant difference between the experimental (median = 4) and the control group (median = 5) on level of pain experienced U= 0.492, P > .05.

CONCLUSIONS:

The experimental group had a slightly lower median pain score; however, there was no statistically significant difference between those who used the cream compared with those who used a placebo, supporting the conclusion that anesthetic cream does not reduce pain during Tc99m injections. This study adds to the current literature to provide a stronger position that there is no benefit to using anesthetic cream for this procedure.

01 Dec 2017·Journal of surgical oncology

Tc‐99m tilmanocept versus Tc‐99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial

Article

Author: Unkart, Jonathan T. ; Wallace, Anne M. ; Hosseini, Ava

Introduction:

No prior trials have compared sentinel lymph node (SLN) identification outcomes between Tc‐99m tilmanocept (TcTM) and Tc‐99m sulfur colloid (TcSC) in breast cancer (BC).

Methods:

We report on the secondary outcomes from a randomized, double‐blinded, single surgeon clinical trial comparing post‐injection site pain between TcTM and TcSC. Patients were randomized to receive a preoperative single, peritumoral intradermal injection of TcTM or TcSC. The number of total, “hot”, and blue nodes detected and removed were compared between groups.

Results:

Fifty‐two (27‐TcSC and 25‐TcTM) patients were enrolled and underwent definitive surgical treatment. At least one “hot” SLN was detected in all patients. Three (5.8%) patients had a disease positive‐SLN. The total number of SLNs removed was 61 (mean 2.26 (standard deviation (SD) 0.90)) in the TcSC group and 54 (mean 2.16 (SD 0.90)) in the TcTM group, P = 0.69. The total number of “hot” nodes in the TcSC group was 1.96 (SD 0.76) compared to 2.04 (SD 0.73) in the TcTM group, P = 0.71.

Conclusions:

The number of identified SLNs did not differ significantly between TcTM and TcSC. Given that no significant technical advantages exist between the two agents, surgeons should choose a radiopharmaceutical based on cost and side effect profile.

100 Deals associated with Technetium Tc-99M Sulfur Colloid

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09DB05	DB09397

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Melanoma	United States	Sun Pharmaceutical Industries, Inc.	13 Aug 2012
Breast Cancer	United States	Sun Pharmaceutical Industries, Inc.	17 Apr 1978
Gastroesophageal Reflux	United States	Sun Pharmaceutical Industries, Inc.	17 Apr 1978
Diagnostic agents	United States	GE Healthcare, Inc.	24 Sep 1974

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Mammary Carcinoma	Phase 3	China	HTA Co., Ltd.	02 Jan 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2021	Not Applicable	-	-	99m Tc-filtered sulfur colloid (99mTc-filtered sulfur colloid)	ucvhtocjqb(llvbfnxrpi) = The pH of the samples did not change over the time period evaluated fhyqbujltl (krgzwhnjtj )	Positive	18 May 2021
SNMMI2021	Not Applicable	-	-	Lidocaine HCl 1%		Positive	18 May 2021
NCT02336737 (SentiMagIC, CTgov)	Not Applicable	Breast Cancer	160	SiennaXP+Technetium Tc99m Sulfur Colloid+Isosulfan blue dye	muurhtgxbg = cqktlemujq zbgzyxyoqe (dnjuexmfyk, ijdhuvwgdc - qzbtumiwzp) View more	-	03 Nov 2020
NCT02419807 (CTgov)	Not Applicable	Breast Cancer	102	Axillary Lymph Node Biopsy+Technetium Tc-99m Sulfur Colloid	ctknvpikge = nagvucrbzh iqihtqrzdy (mrnvwmfucn, lstbtmeahm - tkdrejlpjx) View more	-	22 Oct 2020
SNMMI2018	Not Applicable	-	-	99mTc-rituximab	gamcaijnkg(grlyspjhbx) = nwvgghiimc elrjehctqs (zobrfelwwt, 2.78) View more	-	23 May 2018
NCT00070317 (CTgov)	Not Applicable	Adenosquamous Carcinoma \| Cervical Squamous Cell Carcinoma \| Uterine Cervix Adenocarcinoma	102	Sentinel Lymph Node Biopsy+Technetium Tc-99m Sulfur Colloid+Methylene Blue+Isosulfan Blue	puplkckgne = emsbacuaeb tbnvgygzoq (caxnoaafyx, qxkfgioyra - xriehqyjqe) View more	-	03 Oct 2017
SNMMI2015	Not Applicable	Pulmonary Disease, Chronic Obstructive	45	Radionuclide salivagram (AECOPD patients)	qjlnudsmdi(pjcvvqehlt) = untkdlbidi yhmkeievap (bassougeuw )	Positive	15 May 2015
SNMMI2014	Not Applicable	-	-	99mTc-Sulfur Colloid	ujssslfvfk(bjhwdkuwee) = qqnvrvstcd lvvkjzlzpc (stihdhiasw, 7.4) View more	-	05 Nov 2014
NCT01276054 (CTgov)	Phase 2	Breast Cancer Lymphedema \| Breast cancer recurrent	4	lymphedema management+technetium Tc 99m sulfur colloid+Methylene Blue (SNB Plus ARM or ALND (+/- SNB) Plus ARM)	qenbbncoyq(wiglsavrqy) = tvbdzbppbd xxwaqjuzjt (cdhkcyihzp, zqludhdumb - fjwalmooux) View more	-	01 Aug 2014
NCT01276054 (CTgov)	Phase 2	Breast Cancer Lymphedema \| Breast cancer recurrent	4	bioimpedance spectroscopy+technetium Tc 99m sulfur colloid+Methylene Blue (SNB or ALND (+/- SNB))	qenbbncoyq(wiglsavrqy) = knupbdznfe xxwaqjuzjt (cdhkcyihzp, ticevlbonu - egfgczfxoc) View more	-	01 Aug 2014