NCT05318872

Brief Summary

A new medical optical device named ENDOSWIR is tested to determine its ability to determine if tissues are cancer or normal tissue on ex-vivo condition for specimen of ENT squamous cell cancers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Status
unknown

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

First Submitted

Initial submission to the registry

March 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 12, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

March 21, 2022

Last Update Submit

April 11, 2022

Conditions

Head and Neck Neoplasms

Keywords

Head and neck neoplasmsFluorescenceShort Wave Infra-Red

Outcome Measures

Primary Outcomes (1)

  • Ability of the ENDOSWIR in-vitro diagnostic medical device to distinguish healthy tissue from tumoral tissue on an ENT squamous cell carcinoma resection

    Concordance rate (in %) between the ENDOSWIR result and the final pathological examination.

    1 day

Secondary Outcomes (3)

  • Demonstration that analysis of a sample using the ENDOSWIR device is faster than extemporaneous analysis

    1 day

  • Demonstration of the safety of SWIR.

    1 day

  • Ancillary analysis of special interest areas

    1 day

Study Arms (1)

ENT cancers

patients with ENT cancer in the active care line for who a surgical resection is planned.

Device: ENDOSWIR

Interventions

ENDOSWIRDEVICE

Patients were enrolled for surgery of their cancer and give their consents to the participation to that study. Characteristics of anonymized patient (sex, age, medical history, and tumoral characteristics) will be collected. During surgery, the excisional specimen will be sent in a fresh state for pathological examination (gold standard). The pathologist will determine 10 zones on a cross-section of the specimen which will be analyzed by SWIR, and compared between the two techniques.

ENT cancers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population is selected from the subjects operated on for ENT carcinoma in a programmed manner and as part of the management at the CHUGA. The active file of the CHUGA for an exeresis of squamous cell carcinoma of the oral cavity or oropharynx is about 1 subject per week which should allow to finalize the project in 6 months by supposing that it will be possible to include 50% of the subjects.

You may qualify if:

  • ENT cancer (buccal or oropharyngeal) for which a surgical resection is planned
  • affiliated to the social security
  • Having given his non-opposition to participate in the trial.

You may not qualify if:

  • Patient protected by law (minor, pregnant or breastfeeding woman, patient under guardianship, subject deprived of liberty or hospitalized under restraint).
  • Patients who have received radiotherapy treatment in the VADS area
  • Patient with a history of VADS cancer or a synchronous location of VADS cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wilson RH, Nadeau KP, Jaworski FB, Tromberg BJ, Durkin AJ. Review of short-wave infrared spectroscopy and imaging methods for biological tissue characterization. J Biomed Opt. 2015 Mar;20(3):030901. doi: 10.1117/1.JBO.20.3.030901.

    PMID: 25803186RESULT

  • Kenry, Duan Y, Liu B. Recent Advances of Optical Imaging in the Second Near-Infrared Window. Adv Mater. 2018 Nov;30(47):e1802394. doi: 10.1002/adma.201802394. Epub 2018 Sep 4.

    PMID: 30182451RESULT

  • Hu Z, Fang C, Li B, Zhang Z, Cao C, Cai M, Su S, Sun X, Shi X, Li C, Zhou T, Zhang Y, Chi C, He P, Xia X, Chen Y, Gambhir SS, Cheng Z, Tian J. First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows. Nat Biomed Eng. 2020 Mar;4(3):259-271. doi: 10.1038/s41551-019-0494-0. Epub 2019 Dec 23.

    PMID: 31873212RESULT

  • Schols RM, ter Laan M, Stassen LP, Bouvy ND, Amelink A, Wieringa FP, Alic L. Differentiation between nerve and adipose tissue using wide-band (350-1,830 nm) in vivo diffuse reflectance spectroscopy. Lasers Surg Med. 2014 Sep;46(7):538-45. doi: 10.1002/lsm.22264. Epub 2014 Jun 4.

    PMID: 24895321RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Christian Righini, MD, PhD

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Righini, MD, PhD

CONTACT

0476765656crighini@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 8, 2022

Study Start

April 11, 2022

Primary Completion

September 30, 2022

Study Completion

June 30, 2023

Last Updated

April 12, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share