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

Squamous Cell Carcinoma Clinical Trial

— ClimaBio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450080
• Other study ID #: PI2024_843_0036
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Marc Constans, Pr
• Phone: 03.22.08.75.11
• Email: constans.jean-marc[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Soft Tissue Neoplasms
• Squamous Cell Carcinoma
• Tongue Neoplasms
• Transcriptomics

Intervention

Other:
• 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 .

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery		day 1
Primary	variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery		day 1
Secondary	The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery		day 1
Secondary	The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery		day 1