Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer (Larynx MRI)

April 2, 2020 updated by: Hospices Civils de Lyon
To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with a laryngeal or hypopharyngeal cancer at any stage, with a doubt about cartilage invasion and eligible for surgical treatment.

Description

Inclusion Criteria:

  • Patient ≥18 years old
  • Patient with a laryngeal or hypopharyngeal cancer at any stage
  • Patient eligible for a surgical treatment in multidisciplinary consultation
  • Patient who did not oppose its participation to the study
  • Indication for performing an MRI in addition to CT at the discretion of the investigator

Exclusion Criteria:

  • Patient with an ASA ("American Society of Anesthesiologists", international anesthesia classification) score ≥ 3,
  • Patient with a chirurgical contraindication
  • Patient with a MRI contraindication
  • Pregnant or nursing woman
  • Adult requiring protection (guardianship, supervision)
  • Patient participating in interventional research (Excluding physiological studies and interventional research involving only minimal risks and constraints that do not interfere with the analysis of the primary outcome).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pharyngo laryngeal MRI
Patient with a laryngeal or hypopharyngeal cancer at any stage, with a doubt about cartilage invasion and eligible for surgical treatment for which there is an indication for performing an MRI in addition to CT at the discretion of the investigator
Other: Pharyngo laryngeal MRI

Patients will be outgoing a pharyngolaryngeal MRI, with injection of gadolinium, in addition to the CT imaging. They will have this MRI in case of doubt about cartilage invasion. It will be realised during the time between the CT imaging and the day of surgery.

Device : gadolinium-based MRI contrast agent This will be realized according to the standard procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopy
Time Frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by endoscopy : invaded/non invaded/undetermined
1-4 weeks
CT scan
Time Frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by CT scan : invaded/non invaded/undetermined
1-4 weeks
MRI
Time Frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by MRI : invaded/non invaded/undetermined
1-4 weeks
Anatomopathological analysis
Time Frame: 2-4 weeks
Tumor stage and cartilage invasion as determined by histopathology in excised pieces : invaded/non invaded/undetermined
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Philippe CERUSE, Pr, Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2017

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0632

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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