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Completed

NCT Number: NCT02515084

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Henri Becquerel

Rouen, 76000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET

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

Device

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study 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

Acronym: THYRIRMTEP

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Aug 4, 2015
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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