A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).

This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.

Start Date27 May 2020

Sponsor / Collaborator

Saving Patients' Lives Medical BV

[+3]

NCT02751606

/ Unknown statusPhase 3IIT

Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer

This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.

Start Date01 Jun 2015

Sponsor / Collaborator

Radboud University Medical Center

EUCTR2008-005288-33-GB

/ Not yet recruitingNot Applicable

Methodology Study to develop Sinerem enhanced 3T MR Imaging of Atherosclerotic Plaques within the Carotid Arteries, and to compare Sinerem MRI to contrast enhanced ultrasound

Start Date18 Dec 2008

Sponsor / Collaborator

GlaxoSmithKline Research & Development Ltd.

100 Clinical Results associated with Ferumoxtran-10

100 Translational Medicine associated with Ferumoxtran-10

100 Patents (Medical) associated with Ferumoxtran-10

172

Literatures (Medical) associated with Ferumoxtran-10

07 Jul 2024·PHYSICS IN MEDICINE AND BIOLOGY

Characterization of the clinically approved MRI tracer resotran for magnetic particle imaging in a comparison study

Article

Author: Ackers, Justin ; Vogel, Patrick ; Mohn, Fabian ; Weimer, Agnes ; Ahlborg, Mandy ; Scheffler, Konrad ; Thieben, Florian ; Knopp, Tobias ; Graeser, Matthias ; Wegner, Franz

Abstract:

Objective. The availability of magnetic nanoparticles (MNPs) with medical approval for human intervention is fundamental to the clinical translation of magnetic particle imaging (MPI). In this work, we thoroughly evaluate and compare the magnetic properties of an magnetic resonance imaging (MRI) approved tracer to validate its performance for MPI in future human trials. Approach. We analyze whether the recently approved MRI tracer Resotran is suitable for MPI. In addition, we compare Resotran with the previously approved and extensively studied tracer Resovist, with Ferrotran, which is currently in a clinical phase III study, and with the tailored MPI tracer Perimag. Main results. Initial magnetic particle spectroscopy (MPS) measurements indicate that Resotran exhibits performance characteristics akin to Resovist, but below Perimag. We provide data on four different tracers using dynamic light scattering, transmission electron microscopy, vibrating sample magnetometry measurements, MPS to derive hysteresis, point spread functions, and a serial dilution, as well as system matrix based MPI measurements on a preclinical scanner (Bruker 25/20 FF), including reconstructed images. Significance. Numerous approved MNPs used as tracers in MRI lack the necessary magnetic properties essential for robust signal generation in MPI. The process of obtaining medical approval for dedicated MPI tracers optimized for signal performance is an arduous and costly endeavor, often only justifiable for companies with a well-defined clinical business case. Resotran is an approved tracer that has become available in Europe for MRI. In this work, we study the eligibility of Resotran for MPI in an effort to pave the way for human MPI trials.

01 Jul 2024·Investigative radiology

The Potential of Iron Oxide Nanoparticle-Enhanced MRI at 7 T Compared With 3 T for Detecting Small Suspicious Lymph Nodes in Patients With Prostate Cancer

Article

Author: Fortuin, Ansje S. ; Veltien, Andor ; Scheenen, Tom W. J. ; Hambrock, Thomas ; Quick, Harald H. ; Maas, Marnix C. ; Barentsz, Jelle O. ; Philips, Bart W. J. ; Tenbergen, Carlijn J. A. ; van Asten, Jack J. A. ; Orzada, Stephan

Background:

Accurate detection of lymph node (LN) metastases in prostate cancer (PCa) is a challenging but crucial step for disease staging. Ultrasmall superparamagnetic iron oxide (USPIO)–enhanced magnetic resonance imaging (MRI) enables distinction between healthy LNs and nodes suspicious for harboring metastases. When combined with MRI at an ultra-high magnetic field, an unprecedented spatial resolution can be exploited to visualize these LNs.

Purpose:

The aim of this study was to explore USPIO-enhanced MRI at 7 T in comparison to 3 T for the detection of small suspicious LNs in the same cohort of patients with PCa.

Materials and Methods:

Twenty PCa patients with high-risk primary or recurrent disease were referred to our hospital for an investigational USPIO-enhanced 3 T MRI examination with ferumoxtran-10. With consent, they underwent a 7 T MRI on the same day. Three-dimensional anatomical and T2*-weighted images of both examinations were evaluated blinded, with an interval, by 2 readers who annotated LNs suspicious for metastases. Number, size, and level of suspicion (LoS) of LNs were paired within patients and compared between field strengths.

Results:

At 7 T, both readers annotated significantly more LNs compared with 3 T (474 and 284 vs 344 and 162), with 116 suspicious LNs on 7 T (range, 1–34 per patient) and 79 suspicious LNs on 3 T (range, 1–14 per patient) in 17 patients. For suspicious LNs, the median short axis diameter was 2.6 mm on 7 T (1.3–9.5 mm) and 2.8 mm for 3 T (1.7–10.4 mm, P = 0.05), with large overlap in short axis of annotated LNs between LoS groups. At 7 T, significantly more suspicious LNs had a short axis <2.5 mm compared with 3 T (44% vs 27%). Magnetic resonance imaging at 7 T provided better image quality and structure delineation and a higher LoS score for suspicious nodes.

Conclusions:

In the same cohort of patients with PCa, more and more small LNs were detected on 7 T USPIO-enhanced MRI compared with 3 T MRI. Suspicious LNs are generally very small, and increased nodal size was not a good indication of suspicion for the presence of metastases. The high spatial resolution of USPIO-enhanced MRI at 7 T improves structure delineation and the visibility of very small suspicious LNs, potentially expanding the in vivo detection limits of pelvic LN metastases in PCa patients.

01 Nov 2022·European urology focusQ2 · MEDICINE

Ferumoxtran-10-enhanced 3-T Magnetic Resonance Angiography of Pelvic Arteries: Initial Experience

Q2 · MEDICINE

Article

Author: Gotthardt, Martin ; Hambrock, Thomas ; Zamecnik, Patrik ; Israel, Bas ; Feuerstein, Jürgen ; Nagarajah, James ; Barentsz, Jelle O

BACKGROUND:

Patients with renal impairment cannot undergo angiography because iodine and gadolinium contrast agents are contraindicated. Iron-containing ultrasmall superparamagnetic iron oxide particles, such as ferumoxtran-10, are not contraindicated in these patients. Thus, patients with renal failure can still undergo angiography with ferumoxtran-10.

OBJECTIVE:

To evaluate the visibility of pelvic vessels with magnetic resonance angiography (MRA) using ferumoxtran-10 as contrast agent.

DESIGN, SETTING, AND PARTICIPANTS:

Three hundred and eighty-one patients diagnosed with primary or recurrent prostate cancer underwent pelvic ferumoxtran-10 MRA. Eleven anatomical pelvic-vessel segments per patient were evaluated using qualitative and quantitative criteria for image quality (IQ), vessel visibility (VV), and the contrast-to-noise ratio (CNR).

INTERVENTION:

Ferumoxtran-10-enhaced MRA.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

IQ, VV, and CNR were assessed on a 5-point scale for each data set/vessel segment (very poor, poor, moderate, good, and excellent).

RESULTS AND LIMITATIONS:

IQ was good to excellent for 98.2% of the data sets and VV was good to excellent for 97.7% of all vessel segments. The mean CNR for all segments was 88.13 (standard deviation 4.22). Contrast bolus imaging cannot be performed with this technique, so it is impossible to visualize the arterial or venous phase separately. The timing of contrast administration is also a limitation, with MRA performed 1 d after contrast infusion.

CONCLUSIONS:

Ferumoxtran-10 MRA showed excellent image quality and visibility for pelvic vessels. In addition, the homogeneity of the intraluminal contrast was superior. Patients with preterminal or terminal renal function can benefit from ferumoxtran-10 MRA if visualization of their pelvic vessels is required.

PATIENT SUMMARY:

Magnetic resonance imaging of blood vessels using a contrast agent called ferumoxtran-10 is a promising technique for patients with impaired kidney function, as it provides high-quality visualization of blood vessels in the pelvis.

News (Medical) associated with Ferumoxtran-10

17 Apr 2024

·www.prnewswire.com

Sanochemia: New contrast agent aims to detect the smallest lymphatic metastases in prostate cancer

NEUFELD, Austria, April 17, 2024 /PRNewswire/ -- Sanochemia Pharmazeutika secures exclusive licensing rights to a new MRI contrast agent based on ferumoxtran, that is in an advanced pivotal trial in clinical phase III and may be used to detect the smallest lymph node metastases in prostate cancer patients. The product is already deployed in the Netherlands within an authorized Named-Patient-Use-Program (Artsenverklaring). Continue Reading Official signing of license deal with Thomas Erkinger and Jürgen Feuerstein The agreement with SPL Medical (Nijmegen, Netherlands) grants Sanochemia exclusive worldwide rights for parts of the manufacture and global distribution of an MRI contrast agent based on ferumoxtran with the exception of the DACH region. The product, which is currently under development in late phase III at several renowned European clinics, shall carry the registered trademark Ferrotran®. Ferrotran® contains iron-based superparamagnetic nanoparticles and is intended to be used to detect even the smallest lymph node metastases in prostate cancer patients. Research is being conducted into the possible use for other types of cancer. Ferrotran® will be the second iron-containing product in Sanochemia's gadolinium-free MRI product range. Only recently, an agreement with b.e.imaging (Baden-Baden, Germany) was announced on the MRI contrast agent Resotran® (ferucarbotran) for the detection of focal liver lesions in adults. "The two agreements mark the start of a new product line," said Sanochemia Managing Director Thomas Erkinger. "We are striving to play a pioneering role in the field of gadolinium-free MRI contrast agents. Innovative specialties optimally complement our classic product line in diagnostic imaging". Both products are based on iron-oxide nanoparticles (USPIO/SPIO: Ultrasmall / Small Superparamagnetic Iron Oxide) and expand the diagnostic options within radiology. Dr. Jürgen Feuerstein, CEO of licensor SPL Medical: "We are gaining access to the worldwide market of medical imaging via the extensive marketing network of Sanochemia. Within an authorized named-patient-use-program, more than 700 prostate cancer patients have already been diagnosed in Nijmegen with ferumoxtran in the Netherlands, enabling them to receive earlier and more specific treatment and a significantly higher chance of recovery. The earlier affected lymph nodes are detected, the better the chances of recovery with targeted, less invasive treatment." Sanochemia Pharmazeutika Sanochemia is a leading supplier of pharmaceuticals for radiological applications in the center of Europe. In addition to classic contrast agents, the company focuses on organ-specific and gadolinium-free specialty products. The company's imaging agents are used by doctors and hospitals in over 50 countries worldwide for diagnostic imaging in MR and CT procedures. At the Austrian production site, more than 200 employees ensure that drug products (FDF) and active pharmaceutical ingredients (APIs) are manufactured to the highest pharmaceutical quality standards. Photo: Logo: SOURCE Sanochemia Pharmazeutika

Phase 3License out/in

100 Deals associated with Ferumoxtran-10

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KEGG	Wiki	ATC	Drug Bank
D04176	-	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Lymphoma	NDA/BLA	-	Guerbet France SAS	-
Lymphoma	NDA/BLA	-	AMAG Pharmaceuticals, Inc.	-
Adenosquamous Carcinoma	Phase 2	United States	National Cancer Institute	01 Sep 2007
Adenosquamous Carcinoma	Phase 2	Japan	National Cancer Institute	01 Sep 2007
Adenosquamous Carcinoma	Phase 2	Canada	National Cancer Institute	01 Sep 2007
Carcinosarcoma	Phase 2	United States	National Cancer Institute	01 Sep 2007
Carcinosarcoma	Phase 2	Japan	National Cancer Institute	01 Sep 2007
Carcinosarcoma	Phase 2	Canada	National Cancer Institute	01 Sep 2007
Cervical Squamous Cell Carcinoma	Phase 2	United States	National Cancer Institute	01 Sep 2007
Cervical Squamous Cell Carcinoma	Phase 2	Japan	National Cancer Institute	01 Sep 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASTRO2005	Not Applicable	Pelvic Neoplasms	-	CombidexÂ® (ferumoxtran-10)	xlexaqjihe(phssjvubkk) = czmmuczmmj ewwhlplmak (ascqknlmhc, 1â6.3) View more	-	01 Oct 2005

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