Head and Neck Squamous Cell CarcinomaUSPIO-NECKNCT03817307
Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma
A study testing USPIO-enhanced MRI in people with Head and Neck Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- USPIO-enhanced MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 May 2019to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tim Dijkema, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Daphne Driessen, MD, daphne.driessen@radboudumc.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- USPIO-enhanced MRI
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: USPIO-enhanced MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: The data of each patient will be assessed prior to neck dissection surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start20 May 2019
- Primary completion1 Jun 2022
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Dijkema, MD, PhD, Principal investigator, Radboud University Medical CenterHans Kaanders, Prof, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817307
- Sponsor's protocol ID
- USPIO-NECK
- Acronym
- USPIO-NECK
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2018
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35776432
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT03817307
- Acronym / sponsor ID
- USPIO-NECK / USPIO-NECK
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- Apr 2023 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USPIO enhanced-MRI | Experimental | Diagnostic Test: USPIO-enhanced MRIThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USPIO-enhanced MRIThe 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. | Diagnostic test | USPIO enhanced-MRI |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 35776432Driessen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Dijkema, MD, PhD contact
Tim Dijkema, MD, PhD principal investigator
Radboud University Medical Center
Hans Kaanders, Prof, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USPIO-enhanced MRI in people with Head and Neck Squamous Cell Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Driessen, MD (+31950008371, daphne.driessen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.