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

NCT06450080 | Recruiting

• 1 other identifier: PI2024_843_0036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  day 1

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

  day 1

Secondary Outcomes (2)

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

  day 1

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

  day 1

Study Arms (2)

patients

EXPERIMENTAL

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

Other: MRI and MRS acquisitions

healthy volunteers

ACTIVE COMPARATOR

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

Other: MRI and MRS acquisitions

Interventions

MRI and MRS acquisitions OTHER

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 .

healthy volunteers; patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Jean-Marc Constans, Pr

CONTACT

03.22.08.75.11; constans.jean-marc@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: March 27, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)