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

NCT02876731 | Completed DMC

• 1 other identifier: 2012-A00381-42
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer; Bone Metastasis

Outcome Measures

Primary Outcomes (1)

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

  Up to 38 months

Study Arms (1)

single group

OTHER

PET-CT MRI

Device: PET-CT; Device: MRI

Interventions

PET-CT DEVICE

NaF PET-CT

single group

MRI DEVICE

DWMRI

single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Jean-Godinot: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yacine MERROUCHE

  Institut Jean-Godinot

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 24, 2016
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 24, 2016

Record last verified: 2016-08