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

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

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

Treatments: Other: MRI and MRS acquisitions

Study type: Interventional

Funder types: Other

Identifiers

NCT06450080

PI2024_843_0036

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

patients

Experimental group

Description:

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

Treatment:

Other: MRI and MRS acquisitions

healthy volunteers

Active Comparator group

Description:

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

Treatment:

Other: MRI and MRS acquisitions