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

Completed

• Conditions: Hypopharyngeal Carcinoma; Laryngeal Carcinoma
• Interventions: Other: Pharyngo laryngeal MRI

• Registration Number: NCT03132727
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pharyngo laryngeal MRI	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse; 🇫🇷 Lyon, France