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

August 23, 2016 updated by: Centre Henri Becquerel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • France
      • Rouen, France, 76000
        • Centre Henri Becquerel

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FDG-PET and dw-MRI
At the inclusion, both all patients, a 18F-FDG-PET/CT and a dw-MRI will be performed
Device: 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
Device: MRI imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

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

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Pierre Vera, MD, PhD, Centre Henri Becquerel

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

March 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB 10-03

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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