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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06450080
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Hospitalier Universitaire, Amiens
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Arms

Experimental: patients

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

Active Comparator: 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

Interventions

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 .

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Amiens, Amiens, France

Status

Recruiting

Address

CHU Amiens

Amiens, , 80480

Site Contact

Jean-Marc Constans, Pr

[email protected]

03.22.6608.75.11

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