Soft Tissue Tumors of the TongueClimaBioNCT06450080
Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
A study testing MRI and MRS acquisitions in people with Soft Tissue Tumors of the Tongue and Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Tumors of the Tongue, Squamous Cell Carcinoma, Proton Magnetic Resonance Spectroscopy
- What is being tested?
- MRI and MRS acquisitions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Jean-Marc Constans, Pr, 03.22.6608.75.11, constans.jean-marc@chu-amiens.fr
Sylvie TESTELIN, Pr
About this study
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
- Being tested
- MRI and MRS acquisitions
- Keywords
- Tongue tissue, Squamous Cell Carcinoma, proton magnetic resonance spectroscopy, 1H-MRS, spectroscopic and metabolic profile, noninvasive biomarkers, Transcriptomics
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and MRS acquisitionsOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patients with a lingual tumor measuring less than 15 mm in long axis Receives: 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 Receives: Other: MRI and MRS acquisitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
Measured: day 1
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery
Measured: day 1
Secondary outcomes (2)
The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery
Measured: day 1
The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start27 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Tumors of the TongueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450080
- Sponsor's protocol ID
- PI2024_843_0036
- Acronym
- ClimaBio
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue
- ClinicalTrials.gov ID
- NCT06450080
- Acronym / sponsor ID
- ClimaBio / PI2024_843_0036
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: MRI and MRS acquisitionsPatients with a lingual tumor measuring less than 15 mm in long axis |
| healthy volunteers | Active comparator | Other: MRI and MRS acquisitionsSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- Patients:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and MRS acquisitionsAll 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 . | Other | healthy volunteers, patients |
Primary outcome
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery
Time frame: day 1
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients after surgery
Time frame: day 1
2 secondary outcomes
The variation of lipid contents in the tongue tissue between healthy subjects and patients before surgery
Time frame: day 1
The variation of lipid contents in the tongue tissue between healthy subjects and patients after surgery
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and MRS acquisitions in people with Soft Tissue Tumors of the Tongue and Squamous Cell Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Constans, Pr (03.22.08.75.11, constans.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation in the metabolite TMA-Cho (trimethylamine-choline), between healthy subjects and patients before surgery (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.