NCT02515084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

July 24, 2015

Last Update Submit

August 23, 2016

Conditions

Thyroid CancerRelapse

Keywords

recurrence Thyroid cancer18F-FDG PET-CTdiffusion-weighted Magnetic Resonance Imaging

Outcome Measures

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.

    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

Study Arms (1)

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

Device: PETDevice: MRI imaging

Interventions

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

18F-FDG-PET and dw-MRI
MRI imagingDEVICE
18F-FDG-PET and dw-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Thyroid NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Vera, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

August 4, 2015

Study Start

March 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

FR(1)