Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis (EMOS) (EMOS)

March 12, 2026 updated by: Centre Oscar Lambret

Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis

Breast cancers are among the cancers that metastasize the most to the skeleton. The appearance of bone metastasis, whether they are initials or during a relapse, is a turning point of the disease, due to the additional morbidity they imply (pain, pathologic fractures, hypercalcaemia, neurological compression, etc.). A specific treatment of these metastasis is often undertaken, usually a chemotherapy or hormone therapy. It is important to evaluate the efficacy of this treatment in order to know whether to continue or change it depending on the response observed. But there is no consensus at this time on paraclinical examinations enabling this monitoring. Also, if some criteria for assessing bone metastasis in imaging and nuclear medicine (MDA, PERCIST, EORTC) have been published in the literature, none is formally validated and evaluation in routine practice remains subjective.

The main objective of our study is to determine if the PET-CT and the whole-body MRI are in agreement on the status of bone metastasis (stability, progression, partial response, complete response).

Study Overview

Status

Completed

Conditions

Detailed Description

The oncologist includes patients responding to criteria and not opposing the collection of their data. He submits a request for whole-body MRI and PET-CT to the Medical Imaging and Nuclear Medicine departments of the Oscar Lambret Centre. If the patient has benefited within the previous 15 days of any of these examinations, it is not performed again : it will serve as an initial examination. Following these examinations, the oncologist completes the reading grid. A clinical examination and a questioning with the main stages of the disease is performed and data are reported in the dedicated sheet. A prescription of tumor markers and of bone remodeling is performed (in the absence of recent results), and the results are reported on the same sheet.

After 3 cycles (of intravenous chemotherapy) or 3 months of hormone therapy, the oncologist submits a new request for whole-body MRI and PET-CT. The MRI and PET-CT should conclude to a status : progression, stability, partial response, complete response. The reading grid is completed again. MDA criteria (MRI and PET-CT), PERCIST and EORTC (PET-CT only) are determined. Target lesions (1 to 3) are defined for each examination and a measure of the ADC and the SUV is performed for each lesion on the initial and follow-up examinations.

After these examinations, the patient is reviewed by his oncologist for a new clinical examination, the announcement of the status of bone metastasis and the possible adaptation of the treatment.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients included are patients seen in consultation for discovery or monitoring of breast cancer bone metastasis at the Oscar Lambret Centre, who meet the eligibility criteria and who have given their consent.

Description

Inclusion Criteria:

  1. Patient with breast cancer bone metastasis :

    • at the initial diagnosis (group 1).
    • in a metastatic bone relapse (group 2).
    • with a progression of bone metastasis (group 3).
  2. Treatment (hormone therapy, chemotherapy) not undertaken (group 1) or prior therapeutic change (group 2 and 3).
  3. Patient not opposing the use of its data.

Exclusion Criteria:

  1. Claustrophobic patient
  2. Patient with an uncontrolled diabetes (fasting glucose < 1.6 g / l)
  3. Patient with a pace-maker or another material incompatible with the MRI 3 Tesla
  4. Very algetic patient (Visual Analog Scale (VAS) > 7)
  5. Pregnant or breastfeeding women
  6. Patient under 18 or under guardianship
  7. Movement disorders (Parkinson disease, etc.) or dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients with breast cancer bone metastasis at the initial diagnosis.
Group 2
Patients with breast cancer bone metastasis in a metastatic bone relapse.
Group 3
Patients with breast cancer bone metastasis with a progression of bone metastasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the therapeutic response.
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the concordance of the Apparent Diffusion Coefficient (ADC) and the Standardized Uptake Value (SUV).
Time Frame: At baseline
At baseline
Evaluation of the concordance of the Apparent Diffusion Coefficient (ADC) and the Standardized Uptake Value (SUV).
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)
Evaluation of the consistency in the detection of lesions.
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)
Evaluation of the criteria PERCIST (PET Response Criteria in Solid Tumors)
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)
Evaluation of the criteria MDA (Minimal Disease Activity)
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)
Evaluation of the criteria EORTC (European Organisation for Research and Treatment of Cancer).
Time Frame: Cycle 3 (each cycle is 28 days)
Cycle 3 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Armelle RENAUD, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 12, 2015

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMOS-1207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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