NCT02751606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 6, 2018

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

November 28, 2014

Last Update Submit

December 5, 2018

Conditions

Rectal NeoplasmsBreast Neoplasms

Keywords

FerumoxtranMRI Scans

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Comparison of 7 Tesla and 3 Tesla MRI

    within 2 weeks prior to the patients surgery

Study Arms (1)

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.

Drug: ferumoxtran-10Device: 7 Tesla MRIDevice: 3 Tesla MRI

Interventions

ferumoxtran-10DRUG

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

Breast and rectal cancer
7 Tesla MRIDEVICE

Subjects undergo a 7 Tesla MRI scan

Breast and rectal cancer
3 Tesla MRIDEVICE

Subjects undergo a 3 Tesla MRI scan

Breast and rectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General criteria:
  • Age \> 18 years
  • Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, 6500HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsBreast Neoplasms

Interventions

ferumoxtran-10

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tom Scheenen, PhD

    Radboudumc Nijmegen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Philips, MD

CONTACT

+31 24 36 68392Bart.Philips@radboudumc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

April 26, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2019

Study Completion

November 1, 2019

Last Updated

December 6, 2018

Record last verified: 2017-09

Locations

NL(1)