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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02876731
Acronym
IMMETAOS
Enrollment
13
Registered
2016-08-24
Start date
2013-07-31
Completion date
2015-06-30
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastasis, Cancer

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)

Interventions

DEVICEPET-CT

NaF PET-CT

DEVICEMRI

DWMRI

Sponsors

Institut Jean-Godinot
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolutionUp to 38 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026