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NCT Number: NCT02900118

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

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Treatment (hormone therapy, chemotherapy) not undertaken (group 1) or prior therapeutic change (group 2 and 3).
  • Patient not opposing the use of its data.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Evaluation of the therapeutic response.

    Time frame: Cycle 3 (each cycle is 28 days)

Secondary outcomes

  1. Evaluation of the concordance of the Apparent Diffusion Coefficient (ADC) and the Standardized Uptake Value (SUV).

    Time frame: At baseline

  2. 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)

  3. Evaluation of the consistency in the detection of lesions.

    Time frame: Cycle 3 (each cycle is 28 days)

  4. Evaluation of the criteria PERCIST (PET Response Criteria in Solid Tumors)

    Time frame: Cycle 3 (each cycle is 28 days)

  5. Evaluation of the criteria MDA (Minimal Disease Activity)

    Time frame: Cycle 3 (each cycle is 28 days)

  6. Evaluation of the criteria EORTC (European Organisation for Research and Treatment of Cancer).

    Time frame: Cycle 3 (each cycle is 28 days)

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis

Acronym: EMOS

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Sep 14, 2016
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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