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

Primary Purpose

Cancer, Bone Metastasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET-CT
MRI
Sponsored by
Institut Jean-Godinot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    single group

    Arm Description

    PET-CT MRI

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 12, 2016
    Last Updated
    August 18, 2016
    Sponsor
    Institut Jean-Godinot
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02876731
    Brief Title
    Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases (IMMETAOS)
    Acronym
    IMMETAOS
    Official Title
    Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Jean-Godinot

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Bone Metastasis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    single group
    Arm Type
    Other
    Arm Description
    PET-CT MRI
    Intervention Type
    Device
    Intervention Name(s)
    PET-CT
    Intervention Description
    NaF PET-CT
    Intervention Type
    Device
    Intervention Name(s)
    MRI
    Intervention Description
    DWMRI
    Primary Outcome Measure Information:
    Title
    Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
    Time Frame
    Up to 38 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yacine MERROUCHE
    Organizational Affiliation
    Institut Jean-Godinot
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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