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
About this trial
This is an interventional diagnostic trial for Cancer
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)
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
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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