Thyroid CancerPhase 2THYRIRMTEPNCT02515084
Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma
A Phase 2 study testing PET and MRI imaging in people with Thyroid Cancer and Relapse, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Relapse
- What is being tested?
- PET and MRI imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jul 2016
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female,
- Subjects must be 18 years of age or older,
- Histologically confirmed papillary or follicular differentiated thyroid carcinoma with partial response or complete response, defined by
- Thyroglobulin > 2 μg/L under thyrotrophin stimulation, four months after at least two 131-I based treatments (3,7 GBq/100mCi or more if optimal conditions),
- Negative extension assessment (total body bone scan, (3,7 GBq/100 mCi or more)), echography, CT scan ( neck, thorax, abdomen): no findings..
- Patient's Informed Consent form signed.
Who cannot join
- History of previous cancer within the least three years,
- Performance Status > 2,
- Protected adults
- Any medical, psychological, social or disabling conditions that could interfere or jeopardize the patient's participation
- History of allergy to radio-iodine,
- Estimated GFR < 45 ml/min /m² (MDRD method),
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- Women of childbearing potential without contraceptive method,
- Uncontrolled diabetes mellitus,
- Hypersensitivity to FDG or to any radio-tracers,
- Contraindication to administration of Thyrogen® 0.9mg
- Intraocular foreign bodies or any metallic foreign bodies that contraindicates the MRI.
- Vascular clips, any object or implanted device that could interact with the ferromagnetic field,
- Coronary and peripheral clips, aortic stent grafts, prosthetic heart valves, annuloplasty rings, vena cava filters, cardiac pacemaker, implantable cardiovascular defibrillators....,
- Implanted insulin infuser
- Neurostimulator device
- Claustrophobia
- Agitation or psychological trouble
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study of the Interest of Diffusion-weighted Magnetic Resonance Imaging in the Early Detection of Differentiated Thyroid Carcinoma Cervical Recurrence. Comparison with18F-FDG PET/CT
The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.
Read the detailed description
The schedule and the procedures of the study are the following ones :
- Baseline evaluation :
- Clinical examination with neck echography after rhTSH stimulation
- Normal whole body scan
- First visit (inclusion): 18F-FDG PET/CT DW-MRI of the neck if possible performed shortly after the PET CT or within following days
- Following visits: at 6 months and 12 months
- DW-MRI of the neck performed shortly after the PET CT or within following days.
- Ultrasonography guided fine needle aspiration for cytology for detection of cervical metastases and identifying thyroglobuline in the needle washout fluid if needed and in case of positivity of either PET or DW-MRI exams.
- Histological assessment of biopsies if performed
- Conditions
- Thyroid Cancer, Relapse
- Being tested
- PET, MRI imaging
- Keywords
- recurrence Thyroid cancer, 18F-FDG PET-CT, diffusion-weighted Magnetic Resonance Imaging
- Medical subject headings
- Thyroid Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETDevice
A FDG PET scan and a diffusion-weighted Magnetic Resonance Imaging will be performed to compare the efficacy to diagnose relapse in thyroid carcinoma
MRI imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG-PET and dw-MRI | Experimental | At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed Receives: Device: PET; Device: MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively.
To assess concordance between FDG PET-CT scan and MRI in detection of cervical residual masses in 40 patients in Partial Response or in relapse cervical well-differentiated thyroid carcinoma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Vera, MD, PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515084
- Sponsor's protocol ID
- CHB 10-03
- Acronym
- THYRIRMTEP
- Status last verified
- Aug 2016
- First submitted
- 24 Jul 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of the Interest of Diffusion-weighted Magnetic Resonance Imaging in the Early Detection of Differentiated Thyroid Carcinoma Cervical Recurrence. Comparison with18F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT02515084
- Acronym / sponsor ID
- THYRIRMTEP / CHB 10-03
- Conditions
- Thyroid Cancer, Relapse
- Keywords
- recurrence Thyroid cancer, 18F-FDG PET-CT, diffusion-weighted Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- 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.
The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.
Detailed description
The schedule and the procedures of the study are the following ones :
- Baseline evaluation :
- Clinical examination with neck echography after rhTSH stimulation
- Normal whole body scan
- First visit (inclusion): 18F-FDG PET/CT DW-MRI of the neck if possible performed shortly after the PET CT or within following days
- Following visits: at 6 months and 12 months
- DW-MRI of the neck performed shortly after the PET CT or within following days.
- Ultrasonography guided fine needle aspiration for cytology for detection of cervical metastases and identifying thyroglobuline in the needle washout fluid if needed and in case of positivity of either PET or DW-MRI exams.
- Histological assessment of biopsies if performed
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG-PET and dw-MRI | Experimental | Device: PET, Device: MRI imagingAt the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female,
- Subjects must be 18 years of age or older,
- Histologically confirmed papillary or follicular differentiated thyroid carcinoma with partial response or complete response, defined by
- Patient's Informed Consent form signed.
Key exclusion criteria (17 listed)
- History of previous cancer within the least three years,
- Performance Status > 2,
- Protected adults
- Any medical, psychological, social or disabling conditions that could interfere or jeopardize the patient's participation
- History of allergy to radio-iodine,
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 |
|---|---|---|
| PETA FDG PET scan and a diffusion-weighted Magnetic Resonance Imaging will be performed to compare the efficacy to diagnose relapse in thyroid carcinoma | Device | 18F-FDG-PET and dw-MRI |
| MRI imaging | Device | 18F-FDG-PET and dw-MRI |
Primary outcome
Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively.
Time frame: 1 year
To assess concordance between FDG PET-CT scan and MRI in detection of cervical residual masses in 40 patients in Partial Response or in relapse cervical well-differentiated thyroid carcinoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
Pierre Vera, MD, PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET and MRI imaging in people with Thyroid Cancer and Relapse, run by Centre Henri Becquerel 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 24 Aug 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report of positive or negative results of detection of recurrent lesions from both dw-MRI and 18F-FDG PET/CT. data will be reported extensively and descriptively. (time frame: 1 year). 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 24 Aug 2016.