Exploring the relationship between clinical and biological data in tongue cancer patients
Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
This study is testing a new way to look at the metabolism of tongue tissue in patients with tongue cancer to see if it can help find the cancer earlier and track how well treatments are working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06450080 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Proton Magnetic Resonance Spectroscopy (1H-MRS) to non-invasively assess the metabolic profiles of tongue tissue in patients with squamous cell carcinoma (SCC) compared to healthy subjects. The goal is to identify spectroscopic and metabolic differences that could serve as reliable biomarkers for early detection and monitoring of SCC. Patients with confirmed SCC who have not yet undergone treatment will be evaluated alongside healthy volunteers to establish baseline metabolic profiles. The study aims to enhance diagnostic capabilities and treatment monitoring for this aggressive cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with histologically confirmed squamous cell carcinoma of the tongue who have not yet received treatment.
Not a fit: Patients with tumors measuring less than 15 mm in long axis or those with other histological types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and monitoring of squamous cell carcinoma of the tongue, potentially reducing mortality rates.
How similar studies have performed: Previous studies have shown promise in using 1H-MRS for metabolic profiling in healthy subjects, but this application in SCC is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Jean-Marc Constans, Pr
- Email: constans.jean-marc@chu-amiens.fr
- Phone: 03.22.08.75.11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.