Delving into the Latest Updates on Iodine (124I) Girentuximab with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Diagnostic radiopharmaceuticals

Synonyms

124-Iodine labeled WX-G250, 124-Iodine labeled monoclonal antibody G250, Girentuximab I-124

+ [7]

Target

CAIX

Mechanism

CAIX inhibitors(Carbonic anhydrase IX inhibitors), PET imaging(Positron-emission tomography enhancers)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Transitional Cell CarcinomaTriple Negative Breast Cancer

Inactive Indication

Kidney NeoplasmsRenal Cell Carcinoma

Originator Organization

Heidelberg Pharma AG

Active Organization

Telix Pharmaceuticals Ltd.Heidelberg Pharma Research GmbH

Inactive Organization

Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter

Heidelberg Pharma AG

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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Sequence Code 143780L

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Sequence Code 143552H

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Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors. Sometimes, even when a drug is working, it can take several months before the effects are seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called 124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT scan.
Research has shown that certain proteins in the blood, called antibodies, can attach themselves to cancer cells without binding to normal cells. In this study, an antibody is used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I shows up on the PET scan.

Start Date01 Apr 2012

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT00606632

/ CompletedPhase 3

A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

Start Date01 Mar 2008

Sponsor / Collaborator

Heidelberg Pharma AG

100 Clinical Results associated with Iodine (124I) Girentuximab

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100 Translational Medicine associated with Iodine (124I) Girentuximab

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100 Patents (Medical) associated with Iodine (124I) Girentuximab

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6

Literatures (Medical) associated with Iodine (124I) Girentuximab

01 Mar 2018·Current Opinion in UrologyQ4 · MEDICINE

The role of molecular imaging in the characterization of renal masses

Q4 · MEDICINE

Review

Author: Allaf, Mohamad E ; Gorin, Michael A ; Rowe, Steven P ; Meyer, Alexa R

PURPOSE OF REVIEWTo explore the role of molecular imaging in the characterization of renal masses.RECENT FINDINGSIncidentally detected renal masses exhibit variable malignant potential related to their underlying histology. Patients presenting with a renal mass should undergo individual risk stratification including characterization of their tumor histology. At the present time, anatomical imaging techniques are unable to reliably distinguish between the various renal tumor subtypes. Although renal mass biopsy is helpful in this regard, there are limitations of this procedure. Molecular imaging offers a noninvasive means of determining the histology of renal tumors. Imaging tests that have shown particular promise for this application include I-girentuximab PET/CT for diagnosing clear cell renal cell carcinoma and Tc-sestamibi SPECT/CT for diagnosing renal oncocytomas and hybrid oncocytic/chromophobe tumors.SUMMARYMolecular imaging offers a noninvasive means of determining the histology of renal tumors thereby aiding in the risk stratification of patients presenting with a renal mass. Future work aims to develop a molecular imaging test that employs dual radiotracers allowing for the more precise characterization of renal tumors in a convenient single radiologic study.

01 Sep 2016·Journal of Urology

Diagnostic Challenges of Kidney Cancer: A Systematic Review of the Role of Positron Emission Tomography-Computerized Tomography

Review

Author: Gofrit, Ofer N. ; Orevi, Marina

PURPOSEPositron emission tomography-computerized tomography is a leading imaging modality for many types of solid tumors. The ability to characterize molecular processes noninvasively during a relatively fast whole-body scan is the major advantage of this technology. We reviewed the literature in an attempt to clarify the usefulness of positron emission tomography-computerized tomography in patients with a renal mass.MATERIALS AND METHODSWe searched PubMed® for articles published from 2004 through September 2015 using the keywords "renal," "kidney," "mass," "tumor," "cancer," and "PET/CT."RESULTSA total of 158 relevant articles were included in the review. Most diagnostic studies used (18)F-fluorodeoxyglucose, a marker of glucose metabolism, as the radiotracer. The results were substandard, with sensitivity rates in the range of 31.5% to 77% for diagnosis of renal cell carcinomas. There were higher success rates for diagnosis of clear cell carcinomas. Carbonic anhydrase IX is an enzyme expressed in 95% of clear cell carcinomas but not in normal renal tissue or in benign or nonclear cell malignancies. A chimeric mouse-human antibody to carbonic anhydrase IX labeled with (124)I-girentuximab was demonstrated to diagnose clear cell tumors with sensitivity of 86.2% and specificity of 85.9%. For diagnosis of metastases positron emission tomography-computerized tomography with (18)F-fluorodeoxyglucose was observed to be more accurate than computerized tomography alone (94% vs 89%). Studies with other tracers also reveal encouraging results. Positron emission tomography-computerized tomography holds great promise in predicting prognosis and response to tyrosine kinase inhibitors. Current tyrosine kinase inhibitor treatments usually induce only mild lesion shrinkage. Thus, assessment of response based on changes in size of metastases is insufficient. Low (18)F-fluorodeoxyglucose uptake before treatment and decreased uptake after 2 cycles of treatment are associated with better survival. Using labeled medications as radiotracers before actual treatment may assist in selection of the most effective medication for a specific patient.CONCLUSIONSPositron emission tomography-computerized tomography with (18)F-fluorodeoxyglucose currently has lower sensitivity compared to enhanced computerized tomography for diagnosis of primary renal masses but better sensitivity for diagnosis of metastases. Predicting and monitoring response to targeted therapy could direct the clinician toward drug selection or modification during therapy. The possibility of treating patients with advanced renal cell carcinoma with (124)I-girentuximab attached to (177)Lu, a strong β-emitter, is investigated.

01 Jan 2015·Indian Journal of Urology

Management of urological malignancies: Has positron emission tomography/computed tomography made a difference?

Article

Author: Nirmal, Thampi John ; Kekre, Nitin S

Positron emission tomography/computed tomography (PET/CT) technology has been a significant, but expensive addition to the oncologist's armamentarium. The aim of this review was to determine the clinical utility of PET/CT in urological oncology, its impact on disease outcome and cost-effectiveness. We searched MedLine and peer reviewed journals for all relevant literature available online from the year 2000 until January 2014 regarding the use of PET/CT in the management of urological malignancies. (11)C-choline PET/CT has emerged as a powerful tool for assessment of biochemical relapse in prostate cancer. Use of novel radiotracers like (124)I-girentuximab has shown promise in the diagnosis of clear cell renal carcinoma. Fluorodeoxyglucose PET has a proven role in seminoma for the evaluation of postchemotherapy residual masses and has shown encouraging results when used for detection of metastasis in renal, bladder, and penile cancer. Introduction of novel radiotracers and advanced technology has led to a wider application of PET/CT in urological oncology. However, testicular seminoma aside, its impact on disease outcome and cost-effectiveness still needs to be established.

100 Deals associated with Iodine (124I) Girentuximab

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External Link

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D09632	-	-	DB15025

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Transitional Cell Carcinoma	Phase 2	DE	Heidelberg Pharma Research GmbH	30 Jan 2022
Transitional Cell Carcinoma	Phase 2	AU	Telix Pharmaceuticals Ltd.	30 Jan 2022
Triple Negative Breast Cancer	Phase 1	AU	Telix Pharmaceuticals Ltd.	30 Jan 2022
Triple Negative Breast Cancer	Phase 1	DE	Heidelberg Pharma Research GmbH	30 Jan 2022
Kidney Neoplasms	Phase 1	US	Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter	01 Mar 2008
Renal Cell Carcinoma	Phase 1	US	Heidelberg Pharma AG	01 Mar 2008
Renal Cell Carcinoma	Discovery	US	Heidelberg Pharma AG	01 Mar 2008