Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue

NCT ID: NCT06450080

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2026-06-30

Brief Summary

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Squamous cell carcinoma (SCC) could be a very aggressive cancer and has a bad prognosis if not detected early and thus is associated with high mortality. The development of simple and reliable biomarkers for the early detection of SCC is one of the solutions to better diagnose, treat these tumors, evaluate and monitor treatments, and hence reduce mortality. In a previous work, the investigators demonstrated the ability of Proton Magnetic resonance spectroscopy (1H-MRS) to non-invasively assess spectroscopic and metabolic profiles of tongue tissue in healthy subjects. In the present work, the investigators challenge the use of in-vivo 1H-MRS as a potential method for non-invasive metabolic monitoring of patients with squamous cell carcinoma of the tongue undergoing therapy. Thus the main objective is to study the spectroscopic and metabolic differences, e.g. including variation in the metabolite TMA-Cho (trimethylamine-choline), of tongue tissue between healthy subjects and in patients with squamous cell carcinoma of the tongue, before and after surgery.

Detailed Description

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Conditions

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Soft Tissue Tumors of the Tongue Squamous Cell Carcinoma Proton Magnetic Resonance Spectroscopy Transcriptomics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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patients

Patients with a lingual tumor measuring less than 15 mm in long axis

Group Type EXPERIMENTAL

MRI and MRS acquisitions

Intervention Type OTHER

All MRI and MRS acquisitions for this study will be carried out on the GIE Faire Faces ACHIEVA 3T TX DStream Philips® Research MRI using a 32-channel head antenna located at the Amiens-Picardie University Hospital .

healthy volunteers

Subjects without a history of cancer of the upper aerodigestive tract Subjects without contraindication to MRI Subjects over 18 years old Subjects who have provided free and informed written consent Subjects benefiting from a social security system

Group Type ACTIVE_COMPARATOR

MRI and MRS acquisitions

Intervention Type OTHER

All MRI and MRS acquisitions for this study will be carried out on the GIE Faire Faces ACHIEVA 3T TX DStream Philips® Research MRI using a 32-channel head antenna located at the Amiens-Picardie University Hospital .

Interventions

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MRI and MRS acquisitions

All MRI and MRS acquisitions for this study will be carried out on the GIE Faire Faces ACHIEVA 3T TX DStream Philips® Research MRI using a 32-channel head antenna located at the Amiens-Picardie University Hospital .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients:

* Patients from the maxillofacial surgery department of the Amiens-Picardie University Hospital treated for histologically confirmed squamous cell carcinoma of the tongue
* Patients who have not yet been treated, either surgically or by neoadjuvant treatment
* Patients with a tumor of minimum dimensions of 15 mm in long axis
* Patients without contraindication to MRI
* Patients over 18 years old
* Patients who have provided free and informed written consent
* Patients benefiting from a social security system

Healthy volunteers:

* Subjects without a history of cancer of the upper aerodigestive tract
* Subjects without contraindication to MRI
* Subjects over 18 years old
* Subjects who have provided free and informed written consent
* Subjects benefiting from a social security system

Exclusion Criteria

* Patients:
* Patients with a lingual tumor measuring less than 15 mm in long axis

Patients and healthy volunteers:

* Patients with other histological types of cancer, or other locations
* Subjects with a contraindication to MRI
* Subjects under 18 years old
* Pregnant or breastfeeding women
* Persons under guardianship, curators, protection of justice or deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Marc Constans, Pr

Role: CONTACT

03.22.08.75.11

Facility Contacts

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Jean-Marc Constans, Pr

Role: primary

03.22.6608.75.11

Other Identifiers

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PI2024_843_0036

Identifier Type: -

Identifier Source: org_study_id

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