Head and Neck CancerNCT03991533
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Retrospective Analysis
An observational study of Head and Neck Cancer and Multiparametric MRI, run by AZ Sint-Jan AV.
Trial summary
The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Multiparametric MRI, Cervical Lymph Node
- What is being tested?
- multiparametric MRI
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to Sep 2018
- Phase
- Observational
- 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
Study population: affected group: Histopathologically proven SCC in the HN region control group: Histopathologically proven Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation in the HN region
Who may be able to join
- patients that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018
- histophatologically proven SCC in the head and neck region
- one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report
Who cannot join
- patients not fulfilling abovementioned criteria
- patients with thyroid or skin cancer
- considerable artefact on MRI
- previous surgery, irradiation or chemotherapy in the HN region
About this study
Official title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Read the detailed description
Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.
Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').
Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.
- Being tested
- multiparametric MRI
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric MRIOther
preoperative multiparametric MRI
| Study group | Role | What they receive |
|---|---|---|
| affected | patients with a histologically confirmed head and neck tumour Receives: Other: multiparametric MRI | |
| control | histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation Receives: Other: multiparametric MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
discriminatory value of MRI perfusion curve
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Measured: preoperative
discriminatory value of MRI ADC
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Measured: preoperative
discriminatory value of MRI D-value
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Nov 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991533
- Sponsor's protocol ID
- 2360
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03991533
- Acronym / sponsor ID
- 2360
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Jun 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.
The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Detailed description
Background:The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance.
Objectives: The investigators aim to identify specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region.
Study design: a retrospective study will be set up to explore the diagnostic performance of the selected MRI parameters to differentiate between tumoural and non-tumoural cervical lymph nodes in patients with a histologically confirmed head and neck tumour ('affected group') or histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation ('control group').
Patients will be screened for inclusion in the analysis if they had a routine preoperative multiparametric MRI, according to a standardised protocol, between the 1st of December 2016 and the 30th of September 2018. All MR images will be screened by the resident to select those patients with one or multiple clearly distinguishable metastatic cervical lymph node(s), which can be clearly correlated with the final pathology report. Other strict inclusion criteria are described in detail in the protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| affected | – | Other: multiparametric MRIpatients with a histologically confirmed head and neck tumour |
| control | – | Other: multiparametric MRIhistologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- affected group: Histopathologically proven SCC in the HN region control group: Histopathologically proven Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation in the HN region
Key inclusion criteria (3 listed)
- patients that received a pretreatment multiparametric MRI according to a standardized protocol between December 2016 and December 2018
- histophatologically proven SCC in the head and neck region
- one or multiple clearly distinguishable cervical lymph node(s), that can be unambiguously correlated with the pathology report
Key exclusion criteria (4 listed)
- patients not fulfilling abovementioned criteria
- patients with thyroid or skin cancer
- considerable artefact on MRI
- previous surgery, irradiation or chemotherapy in the HN region
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 |
|---|---|---|
| multiparametric MRIpreoperative multiparametric MRI | Other | affected, control |
Primary outcome
discriminatory value of MRI perfusion curve
Time frame: preoperative
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI ADC
Time frame: preoperative
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI D-value
Time frame: preoperative
differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Johan Abeloos, MD principal investigator
AZ Sint-Lucas Brugge
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Multiparametric MRI, run by AZ Sint-Jan AV.
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 4 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: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discriminatory value of MRI perfusion curve (time frame: preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2022.