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Nano MRI on 7 Tesla in Rectal and Breast Cancer

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ClinicalTrials.gov Identifier: NCT02751606
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Breast Neoplasms Drug: ferumoxtran-10 Device: 7 Tesla MRI Device: 3 Tesla MRI Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer
Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Breast and rectal 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
ferumoxtran-10 will be administered intravenously one day prior to the MRI scan

Device: 7 Tesla MRI
Subjects undergo a 7 Tesla MRI scan

Device: 3 Tesla MRI
Subjects undergo a 3 Tesla MRI scan




Primary Outcome Measures :
  1. Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level. [ Time Frame: within 2 weeks prior to the patients surgery ]
    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.


Secondary Outcome Measures :
  1. Comparison of 7 Tesla and 3 Tesla MRI [ Time Frame: within 2 weeks prior to the patients surgery ]
    The diagnostic accuracy (sensitivity and specificity as described in outcome 1) of 3 Tesla and 7 Tesla will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General criteria:

  • Age > 18 years

Inclusion criteria rectal cancer patients:

  • Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.

Inclusion criteria breast cancer patients:

  • Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.

Exclusion Criteria:

General exclusion criteria:

  • BMI > 30 kg/m2
  • Pregnancy
  • Karnofsky score <= 70
  • Contraindications for 7T MRI:

    • Epilepsy
    • Inability to provide informed consent
    • Metal implants that are not compatible with 7 Tesla MRI
  • Contraindications to USPIO based contrast agents:

    • prior allergic reaction to ferumoxtran-10 or any other iron preparation
    • prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
    • prior allergic reaction to contrast media of any type
    • hereditary hemochromatosis, thalassemia, sickle cell anemia;

Exclusion criteria for rectal cancer:

  • Inflammatory diseases of the abdomen (such as Crohn's disease)
  • Previous abdominal surgery or radiotherapy

Exclusion criteria for breast cancer:

  • Prior radiotherapy or surgery to axillae

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751606


Contacts
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Contact: Bart Philips, MD +31 24 36 68392 Bart.Philips@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Bart Philips, MD    0631961348    bartphilips1@gmail.com   
Principal Investigator: Tom Scheenen, PhD         
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Tom Scheenen, PhD Radboudumc Nijmegen

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02751606     History of Changes
Other Study ID Numbers: 7TNANO1
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: September 2017

Keywords provided by Radboud University:
Ferumoxtran
MRI Scans

Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Rectal Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases