Delving into the Latest Updates on Iobenguane I-123 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Diagnostic radiopharmaceuticals

Synonyms

123I-Iobenguane, 3-Iodobenzylguanidine (123I), 3-Iodobenzylguanidine (123I) Injection

+ [8]

Target-

Mechanism

SPECT(Single-photon emission-computed tomography enhancers)

Therapeutic Areas

NeoplasmsNervous System DiseasesCardiovascular Diseases+ [2]

Active Indication

Lewy Body DiseaseParkinson DiseaseHeart Failure+ [2]

Inactive Indication

Coronary Artery DiseaseHeart failure NYHA class III

Originator Organization

GE Healthcare, Inc.

Active Organization

PDRadiopharma, Inc.

Australian Nuclear Science & Technology OrganisationGE Healthcare, Inc.

Inactive Organization

GE Healthcare Holdings, Inc.

Drug Highest PhaseApproved

First Approval Date

AU (03 Jun 2004),

Neuroblastoma

RegulationOrphan Drug (US)

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Structure/Sequence

Molecular FormulaC8H12IN3O4S

InChIKeyNMHJRGCKGFRFAQ-JZXKKTDRSA-N

CAS Registry139755-80-9

This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They may also affect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.

Start Date31 Dec 2020

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

[+1]

100 Clinical Results associated with Iobenguane I-123

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100 Translational Medicine associated with Iobenguane I-123

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100 Patents (Medical) associated with Iobenguane I-123

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735

Literatures (Medical) associated with Iobenguane I-123

01 Jan 2025·CLINICAL NUCLEAR MEDICINE

A False-Negative 123I-MIBG SPECT/CT With True-Positive 68Ga-DOTATATE PET/CT in a Patient With Neuroblastoma Following 177Lu-DOTATATE Therapy

Article

Author: Lu, Xia ; Yang, Jigang ; Wang, Wei ; Li, Siqi ; Xu, Yanfeng

Abstract:

A 10-year-old girl with high-risk neuroblastoma underwent 123I-MIBG SPECT/CT and 68Ga-DOTATE PET/CT, which both showed multiple bone metastases. However, following 177Lu-DOTATATE therapy, only 68Ga-DOTATATE PET/CT identified residual lesions with negative 123I-MIBG SPECT/CT results. The case emphasized the complementary role of 68Ga-DOTATATE PET/CT and 123I-MIBG SPECT/CT after 177Lu-DOTATATE therapy.

01 Dec 2024·MOLECULAR IMAGING AND BIOLOGY

Usefulness of the Primary Tumor Standardized Uptake Value of Iodine-123 Metaiodobenzylguanidine for Predicting Metastatic Potential in Pheochromocytoma and Paraganglioma

Article

Author: Kamimura, Kiyohisa ; Jinguji, Megumi ; Nakajo, Masatoyo ; Yoshiura, Takashi ; Kitazano, Ikumi ; Tanimoto, Akihide ; Takumi, Koji ; Tani, Atsushi ; Hirahara, Mitsuho

Abstract:

Purpose:

To examine the usefulness of semi-quantitative analysis using the standardized uptake value (SUV) of iodine-123 metaiodobenzylguanidine ([123I]-MIBG) for predicting metastatic potential in patients with pheochromocytoma (PHEO) and paraganglioma (PGL).

Procedures:

This study included 18 PHEO and 2 PGL patients. [123I]-MIBG visibility and SUV-related parameters (SUVmax, SUVmean, tumor volume of [123I]-MIBG uptake [TV_MIBG], and total lesion [123I]-MIBG uptake) were compared with the pathological grading obtained using the Pheochromocytoma of the Adrenal Gland Scaled Score (PASS) and the Grading System for Adrenal Pheochromocytoma and Paraganglioma (GAPP), which are used to predict metastatic potential. The PASS scores were categorized as < 4 and ≥ 4. Based on the GAPP scores, PHEOs/PGLs were categorized as follows: well, moderately, and poorly differentiated tumors. The Mann–Whitney U test or Spearman’s rank correlation was used to assess differences or associations between two quantitative variables.

Results:

All PHEOs/PGLs were visualized on [123I]-MIBG scintigraphy. There were 16 PASS < 4 and 4 PASS ≥ 4 tumors. Moreover, 11 and 9 tumors were well and moderately differentiated, respectively. The uptake scores and SUV-related parameters significantly differed between tumors with a PASS score of < 4 and those with a PASS score of ≥ 4 (each, p > 0.05). Moderately differentiated tumors had significantly higher uptake scores and SUV-related parameters except TV_MIBG than well-differentiated tumors (each, p < 0.05). The GAPP score was positively correlated with the uptake scores and SUV-related parameters (each, p < 0.05) except TV_MIBG.

Conclusions:

The primary tumor [123I]-MIBG uptake assessed using SUV-related parameters can be an imaging tool for predicting metastatic potential in patients with PHEO/PGL.

01 Oct 2024·ANNALS OF NUCLEAR MEDICINE

Sympathetic 123I-metaiodobenzylguanidine index for Lewy body disease: probability-based diagnosis and identifying patients exempt from late imaging

Article

Author: Komatsu, Junji ; Wakabayashi, Hiroshi ; Matsumura, Takeshi ; Kinuya, Seigo ; Nakajima, Kenichi ; Ono, Kenjiro

Abstract:

Objective:

We aimed to establish a practical diagnostic index for Lewy body diseases (LBD), such as Parkinson’s disease and dementia, with Lewy bodies in outpatient settings and criteria for exempting patients from late imaging.

Methods:

We acquired early and late 123I-metaiodobenzylguanidine (MIBG) images from 108 consecutive patients with suspected LBD and standardized heart-to-mediastinum (H/M) ratios for collimator conditions. Exclusions included young-onset Parkinson’s disease (age < 50 years) and genetic transthyretin-type amyloidosis. We developed logistic models incorporating H/M ratios with or without age (n = 92). The sympathetic MIBG index for LBD (SMILe index), categorized LBD likelihood from 0 (lowest) to 1 (highest). Diagnostic accuracy was assessed as the area under the receiver operating characteristic (ROC) curve (AUC). The characteristics of the new index were compared with H/M ratios. The need for late imaging was explored using the SMILe index.

Results:

Early or late SMILe indexes using a single H/M ratio variable discriminated LBD from non-LBD. The AUC values for early and late SMILe indexes were 0.880 and 0.894 (p < 0.0001 for both), identical to those for early and late H/M ratios. The sensitivity and the specificity of early SMILe indexes with a 0.5 threshold were 76% and 90%, achieving accuracy of accuracy 86%. Similarly, the late SMILe index demonstrated a sensitivity of 76% and specificity of 87%, with an accuracy of 84%. Early SMILe indexes < 0.3 or > 0.7 (representing 84% patients) indicated a diagnosis without a late MIBG study.

Conclusion:

The 123I-MIBG-derived SMILe indexes provide likelihood of LBD, and those with a 50% threshold demonstrated optimal diagnostic accuracy for LBD. The index values of either < 0.3 or > 0.7 accurately selected patients who do not need late imaging.

100 Deals associated with Iobenguane I-123

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09	DB09546

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lewy Body Disease	JP	PDRadiopharma, Inc.	22 Dec 2023
Parkinson Disease	JP	PDRadiopharma, Inc.	22 Dec 2023
Heart Failure	US	GE Healthcare, Inc.	20 Mar 2013
Pheochromocytoma	US	GE Healthcare, Inc.	19 Sep 2008
Neuroblastoma	AU	Australian Nuclear Science & Technology Organisation	03 Jun 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart failure NYHA class III	Phase 3	US	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	CA	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	CZ	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	FR	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	DE	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	HU	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	IT	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	NL	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	PL	GE Healthcare Holdings, Inc.	30 Dec 2015
Heart failure NYHA class III	Phase 3	ES	GE Healthcare Holdings, Inc.	30 Dec 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SIOPEN and Curie scores of123I-MIBG scintigraphy in neuroblastoma (EANM2024)	Not Applicable	Neuroblastoma 123I-meta-iodobenzylguanidine (MIBG)	32	123I-MIBG (SIOPEN score)	sxwplabpsg(dbmpsjbzou) = pieoqcaxng xvgtzwyrym (ylxyzhjiqu )	Positive	27 Sep 2024
				123I-MIBG (Curie score)	sxwplabpsg(dbmpsjbzou) = cbeensjmhw xvgtzwyrym (ylxyzhjiqu )
SNMMI2024	Not Applicable	Paraganglioma \| Pheochromocytoma	-	Single-dose MIBG therapy	ggindvrnbj(hscfxkrcqt) = yelsxiatiy ylnzcctqay (durvrrxiqa ) View more	-	09 Jun 2024
				Multiple-dose MIBG therapy	ggindvrnbj(hscfxkrcqt) = ickbjyfkhx ylnzcctqay (durvrrxiqa ) View more
SNMMI2023	Not Applicable	Pheochromocytoma	-	123I-meta-iodobenzylguanidine	hfbbtizcce(mvwvjuupnv) = At each time point, the trends of the biodistribution of ¹²³I-MIBG and ²¹¹At-MABG were almost similar in pheochromocytoma xenograft mice zpeyeopqzi (wwfaczhfcn )	-	28 Aug 2023
				211At-astato-benzylguanidine
SNMMI2023	Not Applicable	Neuroblastoma	-	[18F]mFBG Long Axial Field Of View (LAFOV) PET/CT	lgmgqboiqz(njqlyaayax) = rqbhtmqcht jrauhgtwps (vfeqxnuwiq, 2.6)	-	28 Aug 2023
				[123I]mIBG scintigraphy with single-photon emission computed tomography-CT (SPECT/CT)	lgmgqboiqz(njqlyaayax) = mrwwtzhbdl jrauhgtwps (vfeqxnuwiq, 16.3)
SNMMI2020	Not Applicable	-	-	123I-MIBG	xtudpfzweq(jaksrmpldc) = cajzeqdbdy ewoxrmqbmq (mslfehofuy, 8.86) View more	-	15 May 2020
				211At-MABG	xtudpfzweq(jaksrmpldc) = zojsanhqhb ewoxrmqbmq (mslfehofuy, 4.79) View more
NCT02656329 (ADMIRE-ICD, CTgov)	Phase 3	Heart failure NYHA class III	395	Thyroid blocking+Iobenguane I -123 Injection (AdreView™)	zqzqubrsrj(glpdokpvca) = ftulcefsxa rllknsywfv (lyfxjjkdvu, twjnxuhubn - opcuztqsde) View more	-	22 May 2019
				Implantable Cardioverter Defibrillator+Iobenguane I -123 Injection (Standard of Care)	zqzqubrsrj(glpdokpvca) = nzqycgghtk rllknsywfv (lyfxjjkdvu, yytjplszps - yuetzytffz) View more
EANM2018	Not Applicable	123I-MIBG \| 99mTc-MI-BI	22	123I-MIBG (Responders patients)	gnxdvbimva(pivupjpist) = ssgstjafyw kmbeewoeny (npjoizclfm ) View more	-	18 Sep 2018
EANM2017	Not Applicable	-	-	[18F]FIBG	ufvseuunnm(lqsihhkynf) = tjppdgxfdt lzwsxqpnna (cyekoejiwv, 8.5) View more	-	11 Sep 2017
				[125I]MIBG	wupddhptpm(enhbfhfnci) = epejffclno btwioayvha (kznrodwkgr, 13.3)
SNMMI2017	Not Applicable	High Risk Neuroblastoma 123I-MIBG	76	123I-MIBG (New detailed semi-quantitative scoring system)	ijzkyulebh(wjphsellnt) = dupvcnvssy ycyrxeabog (ymkxhblbqc )	Positive	24 May 2017
COG-A3973 and SIOPEN/HR-NBL1 (EANM2016)	Not Applicable	First line mIBG avid	557	mIBG (Curie-methodology)	gsnigiuvfc(pgjvzagnvs) = wtelcgkupc wmpofubavd (htowftvzjz )	Positive	21 Sep 2016
				mIBG (SIOPEN-methodology)	gsnigiuvfc(pgjvzagnvs) = hdadirnhfi wmpofubavd (htowftvzjz )