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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06450080
Acronym
ClimaBio
Enrollment
60
Registered
2024-06-10
Start date
2024-03-27
Completion date
2026-06-30
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERMRI 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 .

Sponsors

Groupe Hospitalier Pitie-Salpetriere
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgeryday 1
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgeryday 1

Secondary

MeasureTime frame
The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgeryday 1
The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgeryday 1

Countries

France

Contacts

Primary ContactJean-Marc Constans, Pr
constans.jean-marc@chu-amiens.fr03.22.08.75.11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026