Head and Neck CancerNCT03993665
Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis
An observational study of Head and Neck Cancer and Multiparametric MRI, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
The investigators aim to validate 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
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Nov 2018to Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Histopathologically proven SCC in the HN region (affected group) - Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
Who may be able to join
- Patients who received a pretreatment multiparametric MRI according to a standardized protocol
- Histopathologically proven SCC in the HN region (affected group)
- Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
- Patients in whom a or multiple clearly distinguishable cervical lymph node(s) can be observed radiologically, and which can be correlated unambiguously with the pathology report
Who cannot join
- not fulfilling abovementioned criteria
- thyroid or skin cancer
- considerable artefact on MRI
- previously surgery, irradiation or chemotherapy in the HN region
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges
About this study
Official title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis
The investigators aim to validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
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, bone invasion, or tumour relapse in a previously irradiated or operated field 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. Moreover, they could provide additional information about radiation and/or chemotherapeutic efficiency in an individual patient.
Objectives: The investigators aim to validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
Methods: In this trial, a validation cohort will be recruited in a prospective manner, to validate the MRI parameters that showed clinically acceptable discriminant value based on the retrospective study. The values of the selected MRI parameters will be calculated in metastatic lymph nodes of the affected group, for comparison with their values measured in the lymph nodes of a prospectively recruited control group, comprising patients who require the same standardized MRI protocol for evaluation of a Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation, and in whom both the parotid gland lesion and the cervical lymph node are surgically removed for histological confirmation. All included patients of the 'affected group' will also undergo a preoperative positron emission tomography-computed tomography (PET-CT), according to international guidelines, and will preferably receive a multiparametric MRI at 3, 6, 12, 24, 36, 48 and 60 months post treatment as part of routine follow-up.
- Conditions
- Head and Neck Cancer, Multiparametric MRI, Cervical Lymph Node, Bone Invasion, Tumour Relapse, Treatment Response
- 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.
| Study group | Role | What they receive |
|---|---|---|
| affected | All patients with a histologically confirmed squamous cell carcinoma in the head and neck region | |
| control | Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation |
What is being measured
The primary outcome is the main question the study is designed to answer.
discriminatory value of MRI perfusion curve between tumoural and non-tumoural cervical lymph nodes
MRI parameters will be considered validated if they enable 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 value between tumoural and non-tumoural cervical lymph nodes
MRI parameters will be considered validated if they enable 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 between tumoural and non-tumoural cervical lymph nodes
MRI parameters will be considered validated if they enable 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
Secondary outcomes (4)
discriminatory value of perfusion curve between bone invasion and no bone invasion
MRI parameters will be considered validated if they enable differentiation between tumoural bone invasion and no bone invasion, as based on the final pathology report as the 'gold standard'
Measured: preoperative
discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse
MRI parameters will be considered validated if they enable differentiation between post-therapeutic sequelae and tumour relapse, as based on the final pathology report as the 'gold standard'
Measured: follow-up until 5 years postoperative
predictive value of the MRI parameter Ktrans for treatment outcome
predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria
Measured: end of adjuvant radiochemotherapy (approx 10 weeks postoperative)
predictive value of predefined Ktrans for overall and disease-free survival
predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria
Measured: postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start20 Nov 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2028 (estimated)
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
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 5 Years
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
- NCT03993665
- Sponsor's protocol ID
- B049201838067
- 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: a Prospective Analysis
- ClinicalTrials.gov ID
- NCT03993665
- Acronym / sponsor ID
- B049201838067
- Conditions
- Head and Neck Cancer, Multiparametric MRI, Cervical Lymph Node, Bone Invasion, Tumour Relapse, Treatment Response
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 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 validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
Detailed description
Background: The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes, bone invasion, or tumour relapse in a previously irradiated or operated field 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. Moreover, they could provide additional information about radiation and/or chemotherapeutic efficiency in an individual patient.
Objectives: The investigators aim to validate 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. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
Methods: In this trial, a validation cohort will be recruited in a prospective manner, to validate the MRI parameters that showed clinically acceptable discriminant value based on the retrospective study. The values of the selected MRI parameters will be calculated in metastatic lymph nodes of the affected group, for comparison with their values measured in the lymph nodes of a prospectively recruited control group, comprising patients who require the same standardized MRI protocol for evaluation of a Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation, and in whom both the parotid gland lesion and the cervical lymph node are surgically removed for histological confirmation. All included patients of the 'affected group' will also undergo a preoperative positron emission tomography-computed tomography (PET-CT), according to international guidelines, and will preferably receive a multiparametric MRI at 3, 6, 12, 24, 36, 48 and 60 months post treatment as part of routine follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| affected | – | –All patients with a histologically confirmed squamous cell carcinoma in the head and neck region |
| control | – | –Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Histopathologically proven SCC in the HN region (affected group) - Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
Key inclusion criteria (4 listed)
- Patients who received a pretreatment multiparametric MRI according to a standardized protocol
- Histopathologically proven SCC in the HN region (affected group)
- Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
- Patients in whom a or multiple clearly distinguishable cervical lymph node(s) can be observed radiologically, and which can be correlated unambiguously with the pathology report
Key exclusion criteria (4 listed)
- not fulfilling abovementioned criteria
- thyroid or skin cancer
- considerable artefact on MRI
- previously 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.
Primary outcome
discriminatory value of MRI perfusion curve between tumoural and non-tumoural cervical lymph nodes
Time frame: preoperative
MRI parameters will be considered validated if they enable 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 value between tumoural and non-tumoural cervical lymph nodes
Time frame: preoperative
MRI parameters will be considered validated if they enable 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 between tumoural and non-tumoural cervical lymph nodes
Time frame: preoperative
MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
4 secondary outcomes
discriminatory value of perfusion curve between bone invasion and no bone invasion
Time frame: preoperative
discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse
Time frame: follow-up until 5 years postoperative
predictive value of the MRI parameter Ktrans for treatment outcome
Time frame: end of adjuvant radiochemotherapy (approx 10 weeks postoperative)
predictive value of predefined Ktrans for overall and disease-free survival
Time frame: postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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
1 site in 1 country: see every site and its status.
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 at 1 site in Belgium.
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 4 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: under way, not looking for participants, 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.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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 between tumoural and non-tumoural cervical lymph nodes (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.