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Completed

NCT Number: NCT02876731

Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases (IMMETAOS)

Prospective, monocentric, comparative, non randomised

Primary objective :

- to compare the diagnostic accuracy of sodium fluoride PET-CT and MRI using the conventional block and diffusion sequence in the search for bone metastases

Secondary objectives :

* compare accuracy of MRI diffusion and conventional MRI * explore the evolution of the results of the different types of imaging over time or under treatment for patients with repeated examinations at 6 months

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Prospective, monocentric, comparative, non randomised.

Organization of NaF PET-CT and MRI on the same day or within a 10 days period.

At 6 months :

  • repeat both exams systematically if one of the initial tests showed a suspicious or doubtful abnormality
  • final diagnosis by a committee of practitioners using the whole patient's file

Scheduled Project inclusion duration of 36 months (possible adaptation of duration in order to obtain the number of required patients)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man or woman over 18 years
  • Osteophilic cancer (breast, prostate, lung, kidney, thyroid) proved by pathological material, with a high probability of bone metastases
  • With an indication to a bone examination: systematic search for metastasis for the staging or due to clinical or laboratory suspicion of bone metastasis
  • Registered in a social security health scheme
  • Written informed consent obtained

Exclusion criteria

  • Classical contra-indications for PET CT (suspected pregnancy) or MRI (pacemaker, ferromagnetic material); for patients with a possibility of pregnancy (women of childbearing age without contraception and second part of the menstrual cycle, or the slightest suspicion), verification of the absence of pregnancy will be made by the beta HCG dosage before injection of radioactive tracer
  • Uncontrollable claustrophobia with treatment anxiolytic
  • Antitumor treatment started between the two imaging tests
  • Imaging or treatment needed in emergency, if both tests are not performable in time required for the care
  • Inaugural neurological complication
  • Patient unable to undergo biomedical research (under guardianship or deprived of liberty)

Treatment and study plan

PET-CT

Device

NaF PET-CT

MRI

Device

DWMRI

Primary outcomes

  1. Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution

    Time frame: Up to 38 months

Sponsors and collaborators

Lead sponsor

Institut Jean-Godinot

Other

Registry information

Official study title

Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases

Acronym: IMMETAOS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2016
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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