Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Breast Neoplasms

Rectal Neoplasms

Breast Diseases

Skin Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

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.

ferumoxtran-10 will be administered intravenously one day prior to the MRI scan

ferumoxtran-10

7 Tesla MRI

3 Tesla MRI

Bart Philips, MD

Tom Scheenen, PhD

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.

Nano MRI on 7 Tesla in Rectal and Breast Cancer

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

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.

The diagnostic accuracy (sensitivity and specificity as described in outcome 1) of 3 Tesla and 7 Tesla will be compared

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nano MRI on 7 Tesla in Rectal and Breast Cancer	NCT02751606	Rectal Neoplasm... Breast Neoplasm...	ferumoxtran-10 7 Tesla MRI 3 Tesla MRI	18 Years -	Radboud University Medical Center
Nano MRI on 7 Tesla in Rectal and Breast Cancer	NCT02751606	Rectal Neoplasm... Breast Neoplasm...	ferumoxtran-10 7 Tesla MRI 3 Tesla MRI	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for 7 tesla mri

Every month we try and update this database with for 7 tesla mri cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for 7 tesla mri

Every month we try and update this database with for 7 tesla mri cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 7 tesla mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.