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

NCT03991533 | Completed

• 1 other identifier: 2360
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer; Multiparametric MRI; Cervical Lymph Node

Outcome Measures

Primary Outcomes (3)

• 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'

  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'

  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'

  preoperative

Study Arms (2)

affected

patients with a histologically confirmed head and neck tumour

Other: multiparametric MRI

control

histologically confirmed Whartin tumour or pleomorphic adenoma of the parotid gland, without malignant transformation

Other: multiparametric MRI

Interventions

multiparametric MRI OTHER

preoperative multiparametric MRI

affected; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Johan Abeloos, MD

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: June 19, 2019
• Study Start: November 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share