Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02966574
Enrollment
50
Registered
2016-11-17
Start date
2016-12-13
Completion date
2020-12-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breastcancer

Keywords

Whole body MRI, Breastcancer

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.

Interventions

The examination will be conducted in the pretreatment assessment of breast cancers with a high metastasis risk and in the monitoring of metastatic breast cancers. The examination is performed without intravenous injection of contrast medium, from the top of the skull to mid-thigh using diffusion weighted sequences in the axial plane, T1-weighted sequences in the coronal plane, STIR T2 weighted sequences in the coronal plane and T1-weighted sequences in the sagittal plane on the spine. Total examination duration is one hour. The interpretation of the results is made by two independent reporters with a complementary expertise, according to a systematic lecture grid.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Apparent diffusion coefficient (ADC) (mm2/sec)Once per year for a maximum of 2 yearsApparent 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 lesionsOnce per year for a maximum of 2 years
Exact localisation of cancer lesionsOnce per year for a maximum of 2 yearsSystematic 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

Countries

Belgium

Contacts

Primary ContactNathalie Hottat, MD
Nathalie.HOTTAT@chu-brugmann.be32 2 4754187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026