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出境医 / 临床实验 / Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis

Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis

Study Description
Brief 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. 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.

Condition or disease
Head and Neck Cancer Multiparametric MRI Cervical Lymph Node Bone Invasion Tumour Relapse Treatment Response

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
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2028
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  1. 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'

  2. 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'

  3. 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'


Secondary Outcome Measures :
  1. discriminatory value of perfusion curve between bone invasion and no bone invasion [ Time Frame: preoperative ]
    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'

  2. discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse [ Time Frame: follow-up until 5 years postoperative ]
    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'

  3. predictive value of the MRI parameter Ktrans for treatment outcome [ Time Frame: end of adjuvant radiochemotherapy (approx 10 weeks postoperative) ]
    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria

  4. 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 ]
    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
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)

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • not fulfilling abovementioned criteria
  • thyroid or skin cancer
  • considerable artefact on MRI
  • previously surgery, irradiation or chemotherapy in the HN region
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Araceli Diez-Fraile, PhD 0032(0)50459660 araceli.diez-fraile@azsintjan.be

Locations
Layout table for location information
Belgium
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV Recruiting
Bruges, Belgium
Contact: Araceli Diez-Fraile, PhD         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
Layout table for investigator information
Principal Investigator: Johan Abeloos, MD AZ Sint-Jan Brugge-Oostende AV
Tracking Information
First Submitted Date February 13, 2019
First Posted Date June 21, 2019
Last Update Posted Date January 20, 2021
Actual Study Start Date November 20, 2018
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
  • 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'
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 15, 2021)
  • discriminatory value of perfusion curve between bone invasion and no bone invasion [ Time Frame: preoperative ]
    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'
  • discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse [ Time Frame: follow-up until 5 years postoperative ]
    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'
  • predictive value of the MRI parameter Ktrans for treatment outcome [ Time Frame: end of adjuvant radiochemotherapy (approx 10 weeks postoperative) ]
    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria
  • 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 ]
    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria
Original Secondary Outcome Measures
 (submitted: June 18, 2019)
  • discriminatory value of perfusion curve between bone invasion and no bone invasion [ Time Frame: preoperative ]
    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'
  • discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse [ Time Frame: follow-up until 5 years postoperative ]
    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'
  • predictive value of the MRI parameter Ktrans for treatment outcome [ Time Frame: end of adjuvant radiochemotherapy (approx 10 weeks postoperative) ]
    predictive value of MRI parameters for treatment outcome, measured through tumoural response at therapy end based on the RECIST criteria
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Multiparametric MRI in the Management of Head and Neck Cancer: a Prospective Analysis
Official Title Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis
Brief 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. 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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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)

Condition
  • Head and Neck Cancer
  • Multiparametric MRI
  • Cervical Lymph Node
  • Bone Invasion
  • Tumour Relapse
  • Treatment Response
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2028
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • not fulfilling abovementioned criteria
  • thyroid or skin cancer
  • considerable artefact on MRI
  • previously surgery, irradiation or chemotherapy in the HN region
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Araceli Diez-Fraile, PhD 0032(0)50459660 araceli.diez-fraile@azsintjan.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03993665
Other Study ID Numbers B049201838067
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Johan Abeloos, AZ Sint-Jan AV
Study Sponsor AZ Sint-Jan AV
Collaborators Not Provided
Investigators
Principal Investigator: Johan Abeloos, MD AZ Sint-Jan Brugge-Oostende AV
PRS Account AZ Sint-Jan AV
Verification Date January 2021