A Phase 3 interventional study of ferumoxtran-10 and 7 Tesla MRI in Rectal Neoplasms and Breast Neoplasms, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Radboud University Medical Center · Phase 3, Interventional, and Diagnostic
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.
The Presence of lymph node metastases in cancer is a key factor for determining prognosis and forming an adequate treatment plan. Determining lymph node status, however, is a challenge. Ferumoxtran-10, an ultrasmall superparamagnetic iron oxide (USPIO) particle has proven to be a valuable contrast agent for detecting lymph node metastases using magnetic resonance imaging (MRI) in various types of cancer (also called nano-MRI). For small lymph node metastases (\<5mm) the diagnostic accuracy of this technique does, however, drop substantially. Most of the studies that have been performed with these particles used a 1.5 Tesla or 3 Tesla MRI scanner. The investigators would like to increase the resolution of nano-MRI by using a 7 Tesla scanner, such that the investigators can increase the sensitivity of this technique for small lymph nodes. With this study the investigators would like to validate the results of this technique with pathology in rectal and breast cancer. In these cancer types many patients undergo a surgical lymph node dissection by bulk excision of tissue including the nodes, enabling a node-to-node comparison between MRI and pathology to validate our nano-MRI results . If successful this technique would form a non-invasive alternative to the current lymph node staging techniques such as surgery. Additionally (if metastatic nodes are present), it could complement image guided focal therapies on lymph node metastases such as radiotherapy.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
General criteria:
Inclusion criteria rectal cancer patients:
Inclusion criteria breast cancer patients:
Exclusion Criteria:
General exclusion criteria:
Contraindications for 7T MRI:
Contraindications to USPIO based contrast agents:
Exclusion criteria for rectal cancer:
Exclusion criteria for breast cancer:
Subjects will receive intravenous dose of ferumoxtran-10. 24-36 hours later a 7 Tesla MRI scan will be performed, to detect lymph node metastases. In rectal cancer patients the mesorectum will be imaged and for breast cancer patients this will be performed in the ipsilateral axilla. Subjects will also undergo a 3 Tesla MRI scan as a comparison to the 7 Tesla MRI scan.
Drug: ferumoxtran-10 · Device: 7 Tesla MRI · Device: 3 Tesla MRI
ferumoxtran-10 will be administered intravenously one day prior to the MRI scan
Subjects undergo a 7 Tesla MRI scan
Subjects undergo a 3 Tesla MRI scan
Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.
The images of the 7 Tesla MRI scan will be evaluated by a radiologist and every lymph node that is found will be scored as positive or negative. This will be compared to the pathological results to determine the sensitivity and specificity of ferumoxtran enhanced MRI on 7 Tesla for diagnosing whether a lymph node is metastatic or not.
Time frame: within 2 weeks prior to the patients surgery
Comparison of 7 Tesla and 3 Tesla MRI
The diagnostic accuracy (sensitivity and specificity as described in outcome 1) of 3 Tesla and 7 Tesla will be compared
Time frame: within 2 weeks prior to the patients surgery
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center