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

June 4, 2024 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens
        • Sub-Investigator:
          • Stéphanie Dakpé, Pr
        • Sub-Investigator:
          • Sylvie Testelin, Pr
        • Contact:
        • Principal Investigator:
          • Jean-Philippe FOY, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
Patients with a lingual tumor measuring less than 15 mm in long axis
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 .
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
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
Time Frame: day 1
day 1
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery
Time Frame: day 1
day 1
The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Groupe Hospitalier Pitie-Salpetriere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2024_843_0036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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