Back to resultsComparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma (THYRIRMTEP)
Primary Purpose
Thyroid Cancer, Relapse
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
PET
MRI imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Cancer focused on measuring recurrence Thyroid cancer, 18F-FDG PET-CT, diffusion-weighted Magnetic Resonance Imaging
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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),
- 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
Sites / Locations
- Centre Henri Becquerel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FDG-PET and dw-MRI
Arm Description
At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02515084
Brief Title
Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma
Acronym
THYRIRMTEP
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Relapse
Keywords
recurrence Thyroid cancer, 18F-FDG PET-CT, diffusion-weighted Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-FDG-PET and dw-MRI
Arm Type
Experimental
Arm Description
At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed
Intervention Type
Device
Intervention Name(s)
PET
Intervention Description
A FDG PET scan and a diffusion-weighted Magnetic Resonance Imaging will be performed to compare the efficacy to diagnose relapse in thyroid carcinoma
Intervention Type
Device
Intervention Name(s)
MRI imaging
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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),
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vera, MD, PhD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma
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