Magnetic Resonance Imaging of the Whole Body, Including Diffusion, in the Medical Evaluation of Breast Cancers at High Risk for Metastasis and the Follow-up of Metastatic Cancers

Not Applicable

• Conditions: Metastatic Breastcancer
• Interventions: Device: whole body MRI

• Registration Number: NCT02966574
• Lead Sponsor: Brugmann University Hospital

Brief Summary

Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site.

Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.

Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.

Detailed Description

Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers.

Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site. Other sites include the lungs, liver, pleura, distant lymph nodes, soft tissue and the central nervous system.

Metastasis are located exclusively in the bones in 30% of the cases. The most commonly affected bones include the axial skeleton, rich in hematopoietic bone marrow : column, pelvis, skull, ribs, clavicles, the proximal part of the femur and humerus. Five percent of breast cancers are directly metastatic and 20 to 30% of localized breast cancers progress to metastatic stage. This potentially affects a large number of patients, with a median survival of 30 to 36 months.Patients with bone metastases only have a better survival rate than others: 20% at 5 years. It is therefore important to use a reliable and reproducible examination for the monitoring of treatment response.

Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk. However, this is a preliminary study with a limited and heterogeneous cohort of patients.

Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Study Start: 2016-12-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histological diagnosis of breast carcinoma B5
• Axillary lymph node punction C5 or metastatic
• Performance status from 0 to 2.

Exclusion Criteria

• Ferromagnetic metallic foreign bodies (pacemakers, implanted cochlear, neurostimulator, ...)
• Claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
metastatic breast cancer	whole body MRI	-

Primary Outcome Measures

Name	Time	Method
Apparent diffusion coefficient (ADC) (mm2/sec)	Once per year for a maximum of 2 years	Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Number of cancer lesions	Once per year for a maximum of 2 years
Exact localisation of cancer lesions	Once per year for a maximum of 2 years	Systematic lecture grid. Possible choices are: Nodes (Axillary, internal mammary, supra and infraclavicular, cervical, mediastinal, hilar, upper abdomen, pelvic, inguinal), Bone (Spine, Scapular Belt, Costal Grill, Pelvic Belt)- Lungs and pleura - Liver (and other viscera)- Soft tissues and skin- Brain and spinal cord- Other

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium