Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma

NCT ID: NCT02515084

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-07-31

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

Conditions

Thyroid Cancer; Relapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-FDG-PET and dw-MRI

At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed

Group Type: EXPERIMENTAL

PET

Intervention Type: DEVICE

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 imaging

Intervention Type: DEVICE

Interventions

PET

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

MRI imaging

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Henri Becquerel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Vera, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

Centre Henri Becquerel

Rouen, , France

Countries

France

Other Identifiers

CHB 10-03

Identifier Type: -

Identifier Source: org_study_id