NCT03817307

Brief Summary

This study evaluates the diagnostic accuracy of USPIO enhanced MRI for the detection of lymph node metastases in head-and-neck squamous cell carcinoma (SCC) using histopathology as a gold standard.

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
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

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

December 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 26, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

December 20, 2018

Last Update Submit

October 25, 2022

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a level basis.

    The images of the USPIO-enhanced MRI will be read by two radiologists who will score each level as cancer (metastases) positive or negative. These results will be compared with the results of pathology which serve as the gold standard to determine the sensitivity, specificity, positive predictive value and negative predictive value of the USPIO-enhanced MRI for detecting lymph node metastases in head-and-neck cancer patients.

    The data of each patient will be assessed prior to neck dissection surgery.

Secondary Outcomes (1)

  • Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a nodal basis.

    The data of each patient will be assessed prior to neck dissection surgery.

Study Arms (1)

USPIO enhanced-MRI

EXPERIMENTAL

The contrast agent ferumoxtran-10 will be administered intravenously under constant medical supervision 24-36 hours before performing a T2\* weighted MRI scan (prior to surgery).

Diagnostic Test: USPIO-enhanced MRI

Interventions

USPIO-enhanced MRIDIAGNOSTIC_TEST

The USPIO contrast agent will be administered intravenously to the subjects. An MRI scan of the neck region is performed 24-36 hours later to detect lymph node metastases.

USPIO enhanced-MRI

Eligibility Criteria

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

You may qualify if:

  • Patients with histopathologically proven cT0-4N0-3M0 SCC of the oral cavity, oropharynx, hypopharynx, larynx or unknown primary.
  • Patients planned to undergo a neck dissection.
  • Patient provided written informed consent.

You may not qualify if:

  • Patients who underwent radio- and/or chemotherapy to the neck before surgery.
  • Patients who had a previous lymphadenectomy in the head and neck region.
  • Patients with contraindications to MRI (epilepsy; claustrophobia; metallic splinters; pacemaker, pacemaker wires or implanted defibrillator; implanted magnets in jaw; arterial clips (carotid arteries); pregnancy; auditory implant, neurogenic bladder stimulator, insulin pump, neurostimulator, baclofen pump; metallic tissue expander after mastectomy; cochlear implant; metallic braces; other foreign bodies implanted)
  • Patients with contraindications to USPIO based contrast agents (prior allergic reaction to ferumoxtran-10 or any other iron preparation; prior allergic reaction attributed to dextran or other polysaccharide, in any preparation; hereditary hemochromatosis, hemosiderosis, chronic hemolytic anaemia (e.g. thalassemia, sickle cell anaemia); pregnancy)
  • Unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

RECRUITING

Related Publications (1)

  • Driessen DAJJ, Zamecnik P, Dijkema T, Pegge SAH, van Engen-van Grunsven ACH, Takes RP, Kaanders JHAM, Scheenen TWJ. High-Accuracy Nodal Staging of Head and Neck Cancer With USPIO-Enhanced MRI: A New Reading Algorithm Based on Node-to-Node Matched Histopathology. Invest Radiol. 2022 Dec 1;57(12):810-818. doi: 10.1097/RLI.0000000000000902. Epub 2022 Jul 1.

    PMID: 35776432DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Tim Dijkema, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Hans Kaanders, Prof, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Driessen, MD

CONTACT

+31950008371daphne.driessen@radboudumc.nl

Tim Dijkema, MD, PhD

CONTACT

+31243614515

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

January 25, 2019

Study Start

May 20, 2019

Primary Completion

June 1, 2022

Study Completion

April 1, 2023

Last Updated

October 26, 2022

Record last verified: 2022-09

Locations

NL(1)