Head and Neck CancersETCETERANCT06618170
Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
An observational study of Head and Neck Cancers, run by Dyameo.
Trial summary
During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical. It is essential to remove all tumour tissue while preserving as much of the surrounding healthy tissue as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Tissue surface analysis with the device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jul 2025
- 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: Patients diagnosed with squamous cell carcinoma of head and neck for whom surgical removal requiring frozen section analysis is planned.
Who may be able to join
- Confirmed diagnosis of squamous cell carcinoma of the oral cavity, pharynx and/or larynx
- Planned standard surgery with curative intent for squamous cell carcinoma
- Planned surgery includes the performance of extemporaneous biopsies
- Age ≥ 18 years
- Affiliation to a social security scheme
Who cannot join
- Medical or psychiatric conditions that compromise the patient\'s ability to understand the research in which he or she is participating
- Persons of full age subject to a legal protection measure (guardianship or curatorship) or unable to express their non-objection.
- Uncontrolled concomitant medical conditions
- Having received an investigational medicinal product in the 30 days prior to the operation
- History of treatment with anti-EGFR monoclonal antibodies.
- Previously demonstrated absence of EGFR expression by tumour cells.
Trial locations and contacts
No sites are listed yet.
About this study
During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical. It is essential to remove all tumour tissue while preserving as much of the surrounding healthy tissue as possible. Today, surgeons use frozen sections to confirm their decision. Dyameo has developed a device that can identify the presence of tumour markers on the surface of tissue in a matter of seconds, simply by placing the end of a fibre-optic probe in contact with the tissue. This device should enable the surgeon to identify the presence of tumour cells at the margin of the removed tumour.
The aim of this study is to measure the performance of this device. The surgeon will carry out his operation according to his own routine. After collecting tissue for frozen section analysis, he will analyse the tumour specimen using the Dyameo device. After the operation, histological analysis of the removed tumour will enable the precision of the device to be measured and compared with that of the extemporaneous biopsies to guide the surgeon\'s intervention.
Read the detailed description
This will be a mThe surgeon will remove the tumour and collect frozen section according to his usual practices. He will then analyse the same areas on the specimen, or directly analyse the tissue sampled for the frozen section using the Dyameo device. The position of the analysis will be marked on the specimen by sutures. No results will be displayed on the screen at this stage, so as not to influence the doctor;s actions. The surgeon is also free to analyse additional areas with Dyameo device if he or she considers this to be of interest. After the operation, the pathology lab will analyze the tumor specimen to assess the margin status and evaluate the exact nature of the tissues on the localisation of frozen section/Dyameo analysis. Simultaneously, the results of the analyses carried out with the Dyameo device will be exported and analysed (blind to the results of the histological analysis), in order to determine the indications that would have been given to the surgeon during the operation.
The results obtained with the device will be compared with the results of the extemporaneous biopsy analysis. The postoperative histological analysis will serve as a reference.
The performance of the device will be measured by evaluating a posteriori the accuracy of the results provided, and therefore the accuracy of the instructions given to the surgeon during the operation (e.g. additional recutting in the event of the presence of residual tumour cells at the margin of the tumour specimen). The study will also make it possible to calculate sensitivity, specificity, precision, positive and negative predictive values, and relative risk for the device.
- Conditions
- Head and Neck Cancers
- Being tested
- Tissue surface analysis with the device
- Keywords
- guided surgery, head and neck, carcinoma, surgical margin
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue surface analysis with the deviceDiagnostic test
Usage of the device to analyse the presence or absence of tumoral membrane marker at the surface of the removed tumoral specimen
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Dyameo device in guiding surgical procedures
Proportion of cases where analysis with the Dyameo device has provided valid instructions to guide surgery (e.g. make an additional cut if tumour cells are present in at least one area of the resection margin)
Measured: During the surgical intervention
Secondary outcomes (1)
Device performances
Sensibility, specificity, positive and negative predictive value, relative risk of the device
Measured: During the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dyameo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618170
- Sponsor's protocol ID
- 2024-A01462-45
- Acronym
- ETCETERA
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
- ClinicalTrials.gov ID
- NCT06618170
- Acronym / sponsor ID
- ETCETERA / 2024-A01462-45
- Conditions
- Head and Neck Cancers
- Keywords
- guided surgery, head and neck, carcinoma, surgical margin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- DyameoIndustry (pharma, biotech, devices)
- Collaborators
- GETTEC (Groupe d'Etude des Tumeurs de la Tête et du Cou)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical. It is essential to remove all tumour tissue while preserving as much of the surrounding healthy tissue as possible. Today, surgeons use frozen sections to confirm their decision. Dyameo has developed a device that can identify the presence of tumour markers on the surface of tissue in a matter of seconds, simply by placing the end of a fibre-optic probe in contact with the tissue. This device should enable the surgeon to identify the presence of tumour cells at the margin of the removed tumour.
The aim of this study is to measure the performance of this device. The surgeon will carry out his operation according to his own routine. After collecting tissue for frozen section analysis, he will analyse the tumour specimen using the Dyameo device. After the operation, histological analysis of the removed tumour will enable the precision of the device to be measured and compared with that of the extemporaneous biopsies to guide the surgeon\'s intervention.
Detailed description
This will be a mThe surgeon will remove the tumour and collect frozen section according to his usual practices. He will then analyse the same areas on the specimen, or directly analyse the tissue sampled for the frozen section using the Dyameo device. The position of the analysis will be marked on the specimen by sutures. No results will be displayed on the screen at this stage, so as not to influence the doctor;s actions. The surgeon is also free to analyse additional areas with Dyameo device if he or she considers this to be of interest. After the operation, the pathology lab will analyze the tumor specimen to assess the margin status and evaluate the exact nature of the tissues on the localisation of frozen section/Dyameo analysis. Simultaneously, the results of the analyses carried out with the Dyameo device will be exported and analysed (blind to the results of the histological analysis), in order to determine the indications that would have been given to the surgeon during the operation.
The results obtained with the device will be compared with the results of the extemporaneous biopsy analysis. The postoperative histological analysis will serve as a reference.
The performance of the device will be measured by evaluating a posteriori the accuracy of the results provided, and therefore the accuracy of the instructions given to the surgeon during the operation (e.g. additional recutting in the event of the presence of residual tumour cells at the margin of the tumour specimen). The study will also make it possible to calculate sensitivity, specificity, precision, positive and negative predictive values, and relative risk for the device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with squamous cell carcinoma of head and neck for whom surgical removal requiring frozen section analysis is planned.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of squamous cell carcinoma of the oral cavity, pharynx and/or larynx
- Planned standard surgery with curative intent for squamous cell carcinoma
- Planned surgery includes the performance of extemporaneous biopsies
- Age ≥ 18 years
- Affiliation to a social security scheme
Key exclusion criteria (6 listed)
- Medical or psychiatric conditions that compromise the patient\'s ability to understand the research in which he or she is participating
- Persons of full age subject to a legal protection measure (guardianship or curatorship) or unable to express their non-objection.
- Uncontrolled concomitant medical conditions
- Having received an investigational medicinal product in the 30 days prior to the operation
- History of treatment with anti-EGFR monoclonal antibodies.
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 |
|---|---|---|
| Tissue surface analysis with the deviceUsage of the device to analyse the presence or absence of tumoral membrane marker at the surface of the removed tumoral specimen | Diagnostic test | – |
Primary outcome
Efficacy of the Dyameo device in guiding surgical procedures
Time frame: During the surgical intervention
Proportion of cases where analysis with the Dyameo device has provided valid instructions to guide surgery (e.g. make an additional cut if tumour cells are present in at least one area of the resection margin)
1 secondary outcome
Device performances
Time frame: During the surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancers, run by Dyameo.
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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis Saintamand (+0033555782795, contact@dyameo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the Dyameo device in guiding surgical procedures (time frame: During the surgical intervention). 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 2 Oct 2024.