Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma (USPIO-NECK)

October 25, 2022 updated by: Radboud University Medical Center

Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer patients and necessitates treatment intensification. Determining lymph node status, however, is a challenge because up to 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. One promising technique is USPIO-enhanced MRI, an MR-imaging technique in which ultrasmall superparamagnetic iron oxide (USPIO) particles are intravenously infused as a contrast agent in patients 24-36 hours before the MRI examination and has proven to be of value in detecting lymph node metastases in various types of cancer. The investigators want to validate this technique in a cohort of head and neck cancer patients who undergo neck dissection surgery. Histopathology wills serve as the gold standard and the correlation will be made on a (neck)level-to-level and node-to-node basis. Since the investigators have no experience in reading USPIO-enhanced MR images of the neck with 3-dimensional iron-sensitive MR sequences, this study starts with an explorative part and will be followed by the pilot study. The explorative component aims at obtaining knowledge regarding visual features of (non-)metastatic cervical lymph nodes on USPIO-enhanced MR images. The purpose is that the observers work through a learning curve. The information obtained will be used to develop a scoring system for the radiologic assessment of cervical lymph nodes in the subsequent part of our study.

If USPIO-enhanced MRI is successful, this may obviate the need for a sentinel node procedure for example. Furthermore, it could guide treatment such as the performance of more selective neck dissections and de-escalation of the radiation dose to healthy tissues in order to decrease morbidity but maintaining high cure rates.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Tim Dijkema, MD, PhD
  • Phone Number: +31243614515

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: USPIO enhanced-MRI
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a level basis.
Time Frame: The data of each patient will be assessed prior to neck dissection surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of USPIO-enhanced MRI for detecting lymph node metastases on a nodal basis.
Time Frame: The data of each patient will be assessed prior to neck dissection surgery.
The images of the USPIO-enhanced MRI will be read by two radiologists who will score each node 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Tim Dijkema, MD, PhD, Radboud University Medical Center
  • Principal Investigator: Hans Kaanders, Prof, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

June 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USPIO-NECK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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