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

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ClinicalTrials.gov Identifier: NCT02900118
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:

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).


Condition or disease
Breast Cancer

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.


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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Evaluation of the Therapeutic Response of Breast Cancer Bone Metastasis
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.



Primary Outcome Measures :
  1. Evaluation of the therapeutic response. [ Time Frame: Cycle 3 (each cycle is 28 days) ]

Secondary Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900118


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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Principal Investigator: Armelle RENAUD, MD Centre Oscar Lambret

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02900118     History of Changes
Other Study ID Numbers: EMOS-1207
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
Bone metastasis
PET-CT
whole-body MRI
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes