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Nano MRI on 7 Tesla in Rectal and Breast Cancer

Primary Purpose

Rectal Neoplasms, Breast Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
ferumoxtran-10
7 Tesla MRI
3 Tesla MRI
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Neoplasms focused on measuring Ferumoxtran, MRI Scans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Breast and rectal cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2014
Last Updated
December 5, 2018
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02751606
Brief Title
Nano MRI on 7 Tesla in Rectal and Breast Cancer
Official Title
Nano MRI on 7 Tesla: a Technical Validation Study in Rectal and Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Breast Neoplasms
Keywords
Ferumoxtran, MRI Scans

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast and rectal cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ferumoxtran-10
Intervention Description
ferumoxtran-10 will be administered intravenously one day prior to the MRI scan
Intervention Type
Device
Intervention Name(s)
7 Tesla MRI
Intervention Description
Subjects undergo a 7 Tesla MRI scan
Intervention Type
Device
Intervention Name(s)
3 Tesla MRI
Intervention Description
Subjects undergo a 3 Tesla MRI scan
Primary Outcome Measure Information:
Title
Sensitivity and specificity of 7 Tesla MRI in combination with ferumoxtran-10 on nodal level.
Description
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
Secondary Outcome Measure Information:
Title
Comparison of 7 Tesla and 3 Tesla MRI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Philips, MD
Phone
+31 24 36 68392
Email
Bart.Philips@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Scheenen, PhD
Organizational Affiliation
Radboudumc Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Philips, MD
Phone
0631961348
Email
bartphilips1@gmail.com
First Name & Middle Initial & Last Name & Degree
Tom Scheenen, PhD

12. IPD Sharing Statement

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Nano MRI on 7 Tesla in Rectal and Breast Cancer

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