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

Hypopharyngeal Carcinoma Clinical Trial

— Larynx MRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132727
• Other study ID #: 69HCL16_0632
• Status: Completed
• Start date: March 23, 2017
• Est. completion date: November 22, 2019

Study information

• Verified date: April 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Hypopharyngeal Carcinoma
• Hypopharyngeal Neoplasms
• Laryngeal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
France	Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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