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OpenTrials
Completed

NCT Number: NCT03132727

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

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.

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pharyngo laryngeal MRI

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.

Primary outcomes

  1. Endoscopy

    Time frame: 1-4 weeks

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

  2. CT scan

    Time frame: 1-4 weeks

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

  3. MRI

    Time frame: 1-4 weeks

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

  4. Anatomopathological analysis

    Time frame: 2-4 weeks

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Larynx MRI

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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