Evaluation of Neck and Body Metastases to Nodes with Ferumoxtran 10–enhanced MR Imaging: Phase III Safety and Efficacy Study

Anzai, Yoshimi; Piccoli, Catherine W.; Outwater, Eric K.; Stanford, William; Bluemke, David A.; Nurenberg, Pamela; Saini, Sanjay; Maravilla, Kenneth R.; Feldman, David E.; Schmiedl, Udo P.; Brunberg, James A.; Francis, Isaac R.; Harms, Steven E.; Som, Peter M.; Tempany, Clare M.

doi:10.1148/radiol.2283020872

Cited by 268 publications

(177 citation statements)

References 29 publications

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“…The absence of SPIO in lymph nodes as determined by MR imaging has been shown to correlate with disturbances in lymph node flow or architecture due to the presence of metastases. The T2 shortening due to SPIO accumulation was pronounced in normal nodes, allowing for significant increases in positive predictive values and accuracy of diagnosis of node metastases 3 (Fig. 2).…”

Section: Lymph Node Imagingmentioning

confidence: 99%

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Superparamagnetic Iron Oxide Nanoparticle Probes for Molecular Imaging

et al. 2006

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Abstract-The field of molecular imaging has recently seen rapid advances in the development of novel contrast agents and the implementation of insightful approaches to monitor biological processes non-invasively. In particular, superparamagnetic iron oxide nanoparticles (SPIO) have demonstrated their utility as an important tool for enhancing magnetic resonance contrast, allowing researchers to monitor not only anatomical changes, but physiological and molecular changes as well. Applications have ranged from detecting inflammatory diseases via the accumulation of non-targeted SPIO in infiltrating macrophages to the specific identification of cell surface markers expressed on tumors. In this article, we attempt to illustrate the broad utility of SPIO in molecular imaging, including some of the recent developments, such as the transformation of SPIO into an activatable probe termed the magnetic relaxation switch.

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Section: Lymph Node Imagingmentioning

confidence: 99%

“…116 When used as a contrast agent in living subjects, adverse events from USPIO (dextran-coated SPIO) were noted as not serious, mild in severity, and short in duration. 3 The most common reactions were headache, back pain, vasodilatation, and hives. Magnetite biocompatibility has already been proven.…”

Section: Biocompatibilitymentioning

confidence: 99%

Superparamagnetic Iron Oxide Nanoparticle Probes for Molecular Imaging

et al. 2006

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“…Also the introduction of lymph node specific contrast agents like ultrasmall particles iron oxide on magnetic resonance imaging (MRI) provides differentiation between benign and malignant lymph nodes in the head and neck and results are improving [11][12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy and additional value of diffusion-weighted imaging for discrimination of malignant cervical lymph nodes in head and neck squamous cell carcinoma

et al. 2009

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Introduction The aim was to determine the diagnostic accuracy and additional value of diffusion-weighted imaging for detection of malignant lymph nodes in head and neck squamous cell carcinoma.Methods Two hundred nineteen lymph nodes, predominantly smaller than 10 mm (95.4%), in 16 consecutive patients were evaluated at 1.5 T. Lymph nodes were evaluated for maximum short axial diameter, morphological criteria, and apparent diffusion coefficient (ADC) values (b=0 and b=1,000 s/mm 2 ). Sensitivity, specificity, positive and negative predictive values as well as diagnostic odds ratios (DORs) and areas under the curves (AUCs) of ROC curves were calculated for the various magnetic resonance imaging (MRI) criteria individually and in combination. Histological examination of lymph nodes in the neck dissection specimen was the gold standard to determine malignant involvement. Results The optimal ADC threshold was 1.0×10 −3 mm 2 /s. Using this cutoff point, sensitivity and specificity were 92.3% and 83.9%, respectively. When used in combination with size and morphological criteria, ADC value <1.0× 10 −3 mm 2 /s was the strongest predictor of presence of metastasis (DOR=97.6). A model which added ADC values to the other MRI criteria performed significantly better than a model without ADC values: AUC=0.98 versus AUC=0.91 (p=0.036). Conclusion In this study, with predominantly small lymph nodes, the ADC criterion is the strongest independent predictor of presence of metastasis. The use of ADC values in combination with the other MRI criteria significantly improves the discrimination between malignant and benign lymph nodes.

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“…The qualitative analysis was performed 6 months after the completion of the SI measurement study and the criteria reported by previous studies for a diagnosis for USPIO-enhanced MRI was used: a lymph node with an area of high SI on T2-or T2*-weighted images after USPIO administration was considered malignant, and a node with a fatty hilum, a complete signal void, and speckles of granularity without a definite focus of high SI on T2-or T2*-weighted images after USPIO administration was considered nonmalignant (4,5), and a node with a central low SI on T2*-weighted MR imaging after USPIO administration was considered nonmalignant (6). The results of quantitative analysis for the 1.5 T and 3.0 T scanners were assigned to the two investigators.…”

Section: Qualitative Analysis For the Differentiation Of Benign And Mmentioning

confidence: 99%

“…Even though this technique is still not approved by regulatory agencies in North America and Europe, several studies have demonstrated enhanced sensitivity and specificity for malignant lymph node evaluation after the administration of ferumoxtran-10 (Combidex; AMAG Pharmaceuticals, Lexington, MA), a USPIO agent, for pelvic, breast, head and neck, and chest malignancies (4)(5)(6)(7). Diagnostic guidelines for the interpretation of USPIO-enhanced MRI have been reported and the results for the evaluation of malignant lymph nodes with sensitivities and specificities of 79%-91%, and 77%-98%, respectively, have been reported.…”

mentioning

confidence: 99%

Comparison of lymph node metastases assessment With the use of USPIO‐enhanced MR imaging at 1.5 T versus 3.0 T in a rabbit model

Choi¹,

Kim²,

Moon³

et al. 2009

Magnetic Resonance Imaging

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Purpose: To prospectively compare the diagnostic performances of 1.5 T and 3.0 T ultrasmall superparamagnetic iron oxide (USPIO)-enhanced magnetic resonance imaging (MRI) for the detection of lymph node (LN) metastases in a rabbit model. Materials and Methods:Experiments were approved by the animal care committee. VX2 carcinomas were implanted into the thighs of 18 rabbits 3 or 4 weeks before MRI examinations. T2*-weighted 1.5 T and 3.0 T MRI was performed 24 hours after USPIO (2.6 mg/kg iron) administration. Two radiologists calculated signal intensity (SI) ratios (ie, the ratios of postcontrast to precontrast signal intensity) of each LN and also evaluated for the presence of a metastasis in the iliac and retroperitoneal LNs at 1.5 T and 3.0 T MRI. Student's t-test, receiver operating characteristic (ROC) curve analysis, and a Z test were used for the statistical analysis. THE MOST WIDELY EVALUATED intravenous contrast agent for lymphographic magnetic resonance imaging (MRI) is ultrasmall superparamagnetic iron oxide (USPIO) particles, which accumulate slowly in macrophages of the lymph nodes and show a maximum lymphographic effect 24 hours after administration (1-3), whereas nonphagocytic metastatic tissues remain unchanged on USPIO-enhanced MRI. Even though this technique is still not approved by regulatory agencies in North America and Europe, several studies have demonstrated enhanced sensitivity and specificity for malignant lymph node evaluation after the administration of ferumoxtran-10 (Combidex; AMAG Pharmaceuticals, Lexington, MA), a USPIO agent, for pelvic, breast, head and neck, and chest malignancies (4-7). Diagnostic guidelines for the interpretation of USPIO-enhanced MRI have been reported and the results for the evaluation of malignant lymph nodes with sensitivities and specificities of 79%-91%, and 77%-98%, respectively, have been reported. However, the detection of a metastasis 5 mm or less and differentiation of a reactive change of a lymph node is still problematic (8,9). Clinical 3.0 T whole-body MR systems are increasingly available. In addition, a recent study has reported that USPIO-enhanced MRI of pelvic nodes at 3.0 T showed a higher spatial resolution and improved image quality as compared with the image quality at 1.5 T in patients with prostate cancer (10). Therefore, more enhanced accuracy for metastatic

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Evaluation of Neck and Body Metastases to Nodes with Ferumoxtran 10–enhanced MR Imaging: Phase III Safety and Efficacy Study

Cited by 268 publications

References 29 publications

Superparamagnetic Iron Oxide Nanoparticle Probes for Molecular Imaging

Superparamagnetic Iron Oxide Nanoparticle Probes for Molecular Imaging

Diagnostic accuracy and additional value of diffusion-weighted imaging for discrimination of malignant cervical lymph nodes in head and neck squamous cell carcinoma

Comparison of lymph node metastases assessment With the use of USPIO‐enhanced MR imaging at 1.5 T versus 3.0 T in a rabbit model

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