NCT03132727

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 23, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

March 29, 2017

Last Update Submit

April 2, 2020

Conditions

Hypopharyngeal CarcinomaLaryngeal Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Endoscopy

    Tumor stage and cartilage invasion as determined by endoscopy : invaded/non invaded/undetermined

    1-4 weeks

  • CT scan

    Tumor stage and cartilage invasion as determined by CT scan : invaded/non invaded/undetermined

    1-4 weeks

  • MRI

    Tumor stage and cartilage invasion as determined by MRI : invaded/non invaded/undetermined

    1-4 weeks

  • Anatomopathological analysis

    Tumor stage and cartilage invasion as determined by histopathology in excised pieces : invaded/non invaded/undetermined

    2-4 weeks

Study Arms (1)

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

Interventions

Pharyngo laryngeal MRIOTHER

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.

Pharyngo laryngeal MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hypopharyngeal NeoplasmsLaryngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Officials

  • Philippe CERUSE, Pr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 28, 2017

Study Start

March 23, 2017

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

FR(1)