4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

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

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

Study Description
Brief 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.

Condition or disease Intervention/treatment
Head and Neck Cancer Multiparametric MRI Cervical Lymph Node Other: multiparametric MRI

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
Group/Cohort Intervention/treatment
affected
patients with a histologically confirmed head and neck tumour
 Other: multiparametric MRI
preoperative multiparametric MRI
control
histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation
 Other: multiparametric MRI
preoperative multiparametric MRI
Outcome Measures
Primary Outcome Measures :
  1. 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'

  2. 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'

  3. 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'


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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 19, 2019
Last Update Posted Date January 19, 2021
Actual Study Start Date November 1, 2016
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
  • 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'
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
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 Retrospective Analysis
Official Title Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition
  • Head and Neck Cancer
  • Multiparametric MRI
  • Cervical Lymph Node
Intervention Other: multiparametric MRI
preoperative multiparametric MRI
Study Groups/Cohorts
  • affected
    patients with a histologically confirmed head and neck tumour
    Intervention: Other: multiparametric MRI
  • control
    histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation
    Intervention: Other: multiparametric MRI
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 Active, not recruiting
Estimated Enrollment
 (submitted: June 18, 2019) 		30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients not fulfilling abovementioned criteria
  • patients with thyroid or skin cancer
  • considerable artefact on MRI
  • previous surgery, irradiation or chemotherapy in the HN region
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03991533
Other Study ID Numbers 2360
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

治疗医院

新药特效药

前沿医讯