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

NCT ID: NCT03132727

Last Updated: 2020-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2019-11-22

Brief Summary

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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.

Detailed Description

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Conditions

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Hypopharyngeal Carcinoma Laryngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pharyngo laryngeal MRI

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe CERUSE, Pr

Role: PRINCIPAL_INVESTIGATOR

Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse

Locations

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Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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69HCL16_0632

Identifier Type: -

Identifier Source: org_study_id

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