NCT03993665

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Nov 2018Dec 2028

Study Start

First participant enrolled

November 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

5 years

First QC Date

February 13, 2019

Last Update Submit

February 23, 2022

Conditions

Head and Neck CancerMultiparametric MRICervical Lymph NodeBone InvasionTumour RelapseTreatment Response

Outcome Measures

Primary Outcomes (3)

  • 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'

    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'

    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'

    preoperative

Secondary Outcomes (4)

  • discriminatory value of perfusion curve between bone invasion and no bone invasion

    preoperative

  • discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse

    follow-up until 5 years postoperative

  • predictive value of the MRI parameter Ktrans for treatment outcome

    end of adjuvant radiochemotherapy (approx 10 weeks postoperative)

  • predictive value of predefined Ktrans for overall and disease-free survival

    postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Johan Abeloos, MD

    AZ Sint-Lucas Brugge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of department

Study Record Dates

First Submitted

February 13, 2019

First Posted

June 21, 2019

Study Start

November 20, 2018

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 1, 2028

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)