Clinical trial NCT06450080: Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
Official title: Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Tumors of the Tongue
Squamous Cell Carcinoma
Proton Magnetic Resonance Spectroscopy
Transcriptomics
Keywords: Tongue tissue
Squamous Cell Carcinoma
proton magnetic resonance spectroscopy
1H-MRS
spectroscopic and metabolic profile
noninvasive biomarkers
Transcriptomics
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2024-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
timeFrame: day 1
measure: variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery
timeFrame: day 1
Secondary outcomes:
measure: The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery
timeFrame: day 1
measure: The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery
timeFrame: day 1
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: