Hypopharyngeal CarcinomaLarynx MRINCT03132727
Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer
An observational study of Hypopharyngeal Carcinoma and Laryngeal Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypopharyngeal Carcinoma, Laryngeal Carcinoma
- What is being tested?
- Pharyngo laryngeal MRI
- Type of treatment
- Injection or infusion
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2017to 22 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a laryngeal or hypopharyngeal cancer at any stage, with a doubt about cartilage invasion and eligible for surgical treatment.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse
Lyon, 69004
About this study
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.
- Conditions
- Hypopharyngeal Carcinoma, Laryngeal Carcinoma
- Being tested
- Pharyngo laryngeal MRI
- Medical subject headings
- Hypopharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pharyngo laryngeal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy
Tumor stage and cartilage invasion as determined by endoscopy : invaded/non invaded/undetermined
Measured: 1-4 weeks
CT scan
Tumor stage and cartilage invasion as determined by CT scan : invaded/non invaded/undetermined
Measured: 1-4 weeks
MRI
Tumor stage and cartilage invasion as determined by MRI : invaded/non invaded/undetermined
Measured: 1-4 weeks
Anatomopathological analysis
Tumor stage and cartilage invasion as determined by histopathology in excised pieces : invaded/non invaded/undetermined
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start23 Mar 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CERUSE, Pr, Principal investigator, Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132727
- Sponsor's protocol ID
- 69HCL16_0632
- Acronym
- Larynx MRI
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2017
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT03132727
- Acronym / sponsor ID
- Larynx MRI / 69HCL16_0632
- Conditions
- Hypopharyngeal Carcinoma, Laryngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharyngo laryngeal MRI | – | Other: Pharyngo laryngeal MRIPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a laryngeal or hypopharyngeal cancer at any stage, with a doubt about cartilage invasion and eligible for surgical treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngo laryngeal MRIPatients 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. | Other | Pharyngo laryngeal MRI |
Primary outcome
Endoscopy
Time frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by endoscopy : invaded/non invaded/undetermined
CT scan
Time frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by CT scan : invaded/non invaded/undetermined
MRI
Time frame: 1-4 weeks
Tumor stage and cartilage invasion as determined by MRI : invaded/non invaded/undetermined
Anatomopathological analysis
Time frame: 2-4 weeks
Tumor stage and cartilage invasion as determined by histopathology in excised pieces : invaded/non invaded/undetermined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CERUSE, Pr principal investigator
Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypopharyngeal Carcinoma and Laryngeal Carcinoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopy (time frame: 1-4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.