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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast and rectal cancer | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferumoxtran-10 | Drug | ferumoxtran-10 will be administered intravenously one day prior to the MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 2 weeks prior to the patients surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 2 weeks prior to the patients surgery |
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Inclusion Criteria:
General criteria:
Inclusion criteria rectal cancer patients:
Inclusion criteria breast cancer patients:
Exclusion Criteria:
General exclusion criteria:
BMI > 30 kg/m2
Pregnancy
Karnofsky score <= 70
Contraindications for 7T MRI:
Contraindications to USPIO based contrast agents:
Exclusion criteria for rectal cancer:
Exclusion criteria for breast cancer:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bart Philips, MD | Contact | +31 24 36 68392 | Bart.Philips@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tom Scheenen, PhD | Radboudumc Nijmegen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre | Recruiting | Nijmegen | Gelderland | 6500HB | Netherlands |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C097921 | ferumoxtran-10 |
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| 7 Tesla MRI | Device | Subjects undergo a 7 Tesla MRI scan |
|
| 3 Tesla MRI | Device | Subjects undergo a 3 Tesla MRI scan |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |