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Evaluation of Neck and Body Metastases to Nodes with Ferumoxtran 10–enhanced MR Imaging: Phase III Safety and Efficacy Study¹

¹ From the Department of Radiology, University of Washington School of Medicine, Box 357115, 1959 NE Pacific St, Seattle, WA 98195-7115 (Y.A., K.R.M., U.P.S.). The complete list of authors and their affiliations are at the end of this article. Received July 2, 2002; revision requested September 10; revision received October 29; accepted January 14, 2003. Address correspondence to Y.A. (e-mail: anzai@u.washington.edu).

View larger version (62K): [in a new window]   Figure 1. Diagnostic guidelines for ferumoxtran 10-enhanced MR imaging. A lymph node with an area of high SI—encompassing the entire node or a portion of it—was considered metastatic. A node with fatty hilum, complete signal void, and speckles of granularity without a definite focus of high SI was considered nonmetastatic.

View larger version (26K): [in a new window]   Figure 2a. (a) Receiver operating characteristic curves for size criteria at precontrast MR imaging. Area under the curve for size criteria is 0.763. Threshold 1: Lymph nodes larger than 20 mm in diameter are considered metastatic. Threshold 2: Lymph nodes larger than 15 mm in diameter are considered metastatic. Threshold 3: Lymph nodes larger than 10 mm in diameter are considered metastatic. Threshold 4: Lymph nodes larger than 5 mm in diameter are considered metastatic. (b) Receiver operating characteristic curves for postcontrast MR imaging-based diagnostic guidelines (see Fig 1). The area under the curve for postcontrast MR imaging was 0.829. Threshold 1: All lymph nodes assigned a guideline (#1-#7) in Figure 1 are considered nonmetastatic. Threshold 2: All lymph nodes assigned under category 1 are considered metastatic, but nodes assigned under categories 2-7 are considered nonmetastatic. Threshold 3: All lymph nodes assigned under category 1 or 2 are considered metastatic; those assigned under categories 3-7 are considered nonmetastatic. Threshold 4: All lymph nodes assigned under categories 1-3 are considered metastatic; those assigned under categories 4-7 are considered nonmetastatic. Threshold 5: All lymph nodes assigned under categories 1-4 are considered metastatic; those assigned under categories 5-7 are considered nonmetastatic. Threshold 6: All lymph nodes assigned under categories 1-5 are considered metastatic; those assigned under category 6 or 7 are considered nonmetastatic. Threshold 7: All lymph nodes assigned under categories 1-6 are considered metastatic; those assigned under category 7 are considered nonmetastatic.

View larger version (21K): [in a new window]   Figure 2b. (a) Receiver operating characteristic curves for size criteria at precontrast MR imaging. Area under the curve for size criteria is 0.763. Threshold 1: Lymph nodes larger than 20 mm in diameter are considered metastatic. Threshold 2: Lymph nodes larger than 15 mm in diameter are considered metastatic. Threshold 3: Lymph nodes larger than 10 mm in diameter are considered metastatic. Threshold 4: Lymph nodes larger than 5 mm in diameter are considered metastatic. (b) Receiver operating characteristic curves for postcontrast MR imaging-based diagnostic guidelines (see Fig 1). The area under the curve for postcontrast MR imaging was 0.829. Threshold 1: All lymph nodes assigned a guideline (#1-#7) in Figure 1 are considered nonmetastatic. Threshold 2: All lymph nodes assigned under category 1 are considered metastatic, but nodes assigned under categories 2-7 are considered nonmetastatic. Threshold 3: All lymph nodes assigned under category 1 or 2 are considered metastatic; those assigned under categories 3-7 are considered nonmetastatic. Threshold 4: All lymph nodes assigned under categories 1-3 are considered metastatic; those assigned under categories 4-7 are considered nonmetastatic. Threshold 5: All lymph nodes assigned under categories 1-4 are considered metastatic; those assigned under categories 5-7 are considered nonmetastatic. Threshold 6: All lymph nodes assigned under categories 1-5 are considered metastatic; those assigned under category 6 or 7 are considered nonmetastatic. Threshold 7: All lymph nodes assigned under categories 1-6 are considered metastatic; those assigned under category 7 are considered nonmetastatic.

View larger version (30K): [in a new window]   Figure 3a. Bar graphs show sensitivities, specificities, and accuracies of size criteria at precontrast (Pre-Dose) MR imaging (light gray bar), reader assessment at precontrast MR imaging (white bar), paired MR imaging (black bar), and postcontrast (Post-Dose) MR imaging only (dark gray bar) in (a) head and neck, (b) chest and mediastinum, (c) breast, and (d) abdomen and pelvis. Diagnostic performance improved in all regions except the chest and mediastinum. Ferumoxtran 10 performed best in the head and neck region, yielding sensitivity of 96%, specificity of 87%, and overall accuracy of 93% (average of two blinded readers [BR]). The numbers of lymph nodes depicted at MR imaging in each region are listed at the bottom of each figure. Dx = diagnosis.

View larger version (30K): [in a new window]   Figure 3b. Bar graphs show sensitivities, specificities, and accuracies of size criteria at precontrast (Pre-Dose) MR imaging (light gray bar), reader assessment at precontrast MR imaging (white bar), paired MR imaging (black bar), and postcontrast (Post-Dose) MR imaging only (dark gray bar) in (a) head and neck, (b) chest and mediastinum, (c) breast, and (d) abdomen and pelvis. Diagnostic performance improved in all regions except the chest and mediastinum. Ferumoxtran 10 performed best in the head and neck region, yielding sensitivity of 96%, specificity of 87%, and overall accuracy of 93% (average of two blinded readers [BR]). The numbers of lymph nodes depicted at MR imaging in each region are listed at the bottom of each figure. Dx = diagnosis.

View larger version (29K): [in a new window]   Figure 3c. Bar graphs show sensitivities, specificities, and accuracies of size criteria at precontrast (Pre-Dose) MR imaging (light gray bar), reader assessment at precontrast MR imaging (white bar), paired MR imaging (black bar), and postcontrast (Post-Dose) MR imaging only (dark gray bar) in (a) head and neck, (b) chest and mediastinum, (c) breast, and (d) abdomen and pelvis. Diagnostic performance improved in all regions except the chest and mediastinum. Ferumoxtran 10 performed best in the head and neck region, yielding sensitivity of 96%, specificity of 87%, and overall accuracy of 93% (average of two blinded readers [BR]). The numbers of lymph nodes depicted at MR imaging in each region are listed at the bottom of each figure. Dx = diagnosis.

View larger version (30K): [in a new window]   Figure 3d. Bar graphs show sensitivities, specificities, and accuracies of size criteria at precontrast (Pre-Dose) MR imaging (light gray bar), reader assessment at precontrast MR imaging (white bar), paired MR imaging (black bar), and postcontrast (Post-Dose) MR imaging only (dark gray bar) in (a) head and neck, (b) chest and mediastinum, (c) breast, and (d) abdomen and pelvis. Diagnostic performance improved in all regions except the chest and mediastinum. Ferumoxtran 10 performed best in the head and neck region, yielding sensitivity of 96%, specificity of 87%, and overall accuracy of 93% (average of two blinded readers [BR]). The numbers of lymph nodes depicted at MR imaging in each region are listed at the bottom of each figure. Dx = diagnosis.

View larger version (123K): [in a new window]   Figure 4a. Lung cancer in 69-year-old man. Transverse (a) contrast-enhanced CT image and (b) precontrast T1-weighted (1,176/11, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), and (d) postcontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view) MR images of the chest show right precarinal lymph node (arrow) approximately 2 cm in diameter. In c, the precarinal lymph node is hyperintense. In d, there are no significant changes in precarinal lymph node SI. These findings indicate the presence of a metastatic node. Tumor involvement was confirmed at surgery.

View larger version (151K): [in a new window]   Figure 4b. Lung cancer in 69-year-old man. Transverse (a) contrast-enhanced CT image and (b) precontrast T1-weighted (1,176/11, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), and (d) postcontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view) MR images of the chest show right precarinal lymph node (arrow) approximately 2 cm in diameter. In c, the precarinal lymph node is hyperintense. In d, there are no significant changes in precarinal lymph node SI. These findings indicate the presence of a metastatic node. Tumor involvement was confirmed at surgery.

View larger version (121K): [in a new window]   Figure 4c. Lung cancer in 69-year-old man. Transverse (a) contrast-enhanced CT image and (b) precontrast T1-weighted (1,176/11, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), and (d) postcontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view) MR images of the chest show right precarinal lymph node (arrow) approximately 2 cm in diameter. In c, the precarinal lymph node is hyperintense. In d, there are no significant changes in precarinal lymph node SI. These findings indicate the presence of a metastatic node. Tumor involvement was confirmed at surgery.

View larger version (139K): [in a new window]   Figure 4d. Lung cancer in 69-year-old man. Transverse (a) contrast-enhanced CT image and (b) precontrast T1-weighted (1,176/11, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), (c) precontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view), and (d) postcontrast T2*-weighted gradient-echo (50/15, 25° flip angle, two signals acquired, 256 x 192 matrix, 5-mm section thickness, 36-cm field of view) MR images of the chest show right precarinal lymph node (arrow) approximately 2 cm in diameter. In c, the precarinal lymph node is hyperintense. In d, there are no significant changes in precarinal lymph node SI. These findings indicate the presence of a metastatic node. Tumor involvement was confirmed at surgery.