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

Cancer Clinical Trial

— IMMETAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876731
• Other study ID #: 2012-A00381-42
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: August 18, 2016
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2016
• Source: Institut Jean-Godinot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Cancer
• Neoplasm Metastasis

Intervention

Device:
• PET-CT
NaF PET-CT
• MRI
DWMRI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Jean-Godinot

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution		Up to 38 months	No