CancerIMMETAOSNCT02876731

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

A study testing PET-CT and MRI in people with Cancer and Bone Metastasis, run by Institut Jean-Godinot.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Bone Metastasis
What is being tested?: PET-CT and MRI
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: No sites listed yet
Study dates: Jul 2013to Jun 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

About this study

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

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

Read the 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)

Conditions: Cancer, Bone Metastasis
Being tested: PET-CT, MRI
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PET-CTDevice
NaF PET-CT
MRIDevice
DWMRI

Study groups in NCT02876731
Study group	Role	What they receive
single group	Other	PET-CT MRI Receives: Device: PET-CT; Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
Measured: Up to 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jun 2015

First posted24 Aug 2016 (estimated)
Study startJul 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02876731
Sponsor's protocol ID: 2012-A00381-42
Acronym: IMMETAOS
Status last verified: Aug 2016
First submitted: 12 Aug 2016
Last updated: 24 Aug 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of NaF PET-CT and Diffusion MRI in the Diagnosis of Bone Metastases
ClinicalTrials.gov ID: NCT02876731
Acronym / sponsor ID: IMMETAOS / 2012-A00381-42
Conditions: Cancer, Bone Metastasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Institut Jean-GodinotUniversity, hospital or other
Study start: Jul 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 24 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single group	Other	Device: PET-CT, Device: MRIPET-CT MRI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PET-CTNaF PET-CT	Device	single group
MRIDWMRI	Device	single group

Primary outcome

Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution
Time frame: Up to 38 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
Individual participant dataSharing planned: Undecided

Related trials for Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yacine MERROUCHE study director

Institut Jean-Godinot

Questions about this trial

What is this clinical trial studying?

A study testing PET-CT and MRI in people with Cancer and Bone Metastasis, run by Institut Jean-Godinot.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Bone metastasis according to a clinician and imaging practitionners group based on clinical and imaging evolution (time frame: Up to 38 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02876731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.