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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Patients with other histological types of cancer, or other locations

Subjects with a contraindication to MRI

Subjects under 18 years old

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRI and MRS acquisitions

    Other intervention

    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 .

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: patientsExperimental treatment 1 intervention
Group B: healthy volunteersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery

Time frame
day 1
2

variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery

Time frame
day 1

Secondary outcomes

1

The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery

Time frame
day 1
2

The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery

Time frame
day 1

Other outcomes

Sponsors and contacts

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Centre Hospitalier Universitaire, Amiens

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborator