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

August 18, 2016 updated by: Institut Jean-Godinot

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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
Other: single group
PET-CT MRI
Device: PET-CT
NaF PET-CT
Device: MRI
DWMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
Time Frame: Up to 38 months
Up to 38 months

Collaborators and Investigators

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

Sponsor

Institut Jean-Godinot

Investigators

  • Study Director: Yacine MERROUCHE, Institut Jean-Godinot

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

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00381-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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