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

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

NCT ID: NCT06450080

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

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Soft Tissue Neoplasms
Tongue Neoplasms

Conditions: Keywords:
Tongue tissue
Squamous Cell Carcinoma
proton magnetic resonance spectroscopy
1H-MRS
spectroscopic and metabolic profile
noninvasive biomarkers
Transcriptomics

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Participant)

Intervention:

Intervention type: Other
Intervention name: MRI and MRS acquisitions
Description: 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 .
Arm group label: healthy volunteers
Arm group label: patients

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: CHU Amiens

Address:
City: Amiens
Zip: 80480
Country: France

Status: Recruiting

Contact:
Last name: Jean-Marc Constans, Pr

Phone: 03.22.6608.75.11
Email: constans.jean-marc@chu-amiens.fr

Investigator:
Last name: Sylvie TESTELIN, Pr
Email: Sub-Investigator

Investigator:
Last name: Stéphanie DAKPE, Pr
Email: Sub-Investigator

Investigator:
Last name: Jean-Philippe FOY, Pr
Email: Principal Investigator

Start date: March 27, 2024

Completion date: June 2026

Lead sponsor:
Agency: Centre Hospitalier Universitaire, Amiens
Agency class: Other

Collaborator:
Agency: Groupe Hospitalier Pitie-Salpetriere
Agency class: Other

Source: Centre Hospitalier Universitaire, Amiens

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06450080