Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.
Whole Body-Magnetic Resonance Imaging (WB-MRI) is a radiation-free and, usually, contrast administration-free imaging method for detecting bone and soft tissue pathology. It's part of the "next generation imaging techniques" combining high quality morphological images with "functional" information on diffusivity of water molecules through diffusion- weighted sequences (DWI). Nowadays WB-MRI has been introduced in several guidelines in oncological settings, in particular for staging and relapse in patients affected by monoclonal plasma cell disorders, screening in patients with cancer predisposition syndromes (Li fraumeni syndrome, hereditary paraganglioma / pheochromocytoma syndrome, neurofibromatosis) and staging and follow-up of cancer patients affected by predominant bone metastatic pattern, particularly advanced prostate cancer and breast cancer. The current limit on the diffusion of the technique is that it is not widely available as it requires an optimal set up of both the machine with specific sequences and the acquisition protocol, as well as dedicated, trained staff. DWI is emerging as a core sequence of WB-MRI protocols for disease assessment because of its sensitiveness to tissue cellularity and cell viability offering excellent lesion-to-background contrast and quantification of the degree of water motion by calculation of the apparent diffusion coefficient (ADC); changes in ADC can reflect variations in cellularity. Fat-Fraction (FF) is another emerging sequence for tissue characterization that quantifies the relative amount of fat. A better investigation of these novel sequences can maximize sensitivity and specificity in order to improve our understanding of diseases assessment. The aim of this observational study is to evaluate whether WB-MRI allows an improvement in identification of site of tumour disease or earlier progression in comparison to other methodologies that are nowadays the standard of care due to their widespread availability in hospitals and quicker execution, particularly Bone Scintigraphy (BS) Computed Tomography (CT), Positron Emission Tomography/Computed Tomography (PET/CT) .
Study Type
OBSERVATIONAL
Enrollment
1,000
This is a non-pharmacological, observational, prospective, study. Each patient will undergo quantitative WB-MRI as per clinical routine. WB-MRI may be performed: * at staging * at follow-up Disease progression is defined by clinicians taking into account all imaging modalities and clinicolaboratorial data available for the patients.
IRCCS - Azienda Ospedaliero-Universitaria di Bologna - Policlinico di S. Orsola
Bologna, BO, Italy
RECRUITINGIRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, FC, Italy
RECRUITINGIRCCS Istituto Europeo di Oncologia S.r.l.
Milan, MI, Italy
NOT_YET_RECRUITINGTo evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
To evaluate the accuracy of WB-MRI in terms of: Myeloma: pattern of bone marrow or soft tissues involvement (Negative /Micronodular/ diffuse/focal/ focal on diffuse/ extra and perimedullary disease)
Time frame: 36 months
To evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
To evaluate the accuracy of WB-MRI in terms of: -Metastatic breast cancer an Metastatic prostate cancer: Number of lesions for oligometastatic patients or diffuse pattern for diffuse bone marrow involvement
Time frame: 36 months
To evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
To evaluate the accuracy of WB-MRI in terms of: -Lymphoma:number of lesions will be assessed.
Time frame: 36 months
To evaluate whether WB-MRI allows a better evaluation of bone marrow involvement and/or soft tissue lesions in different kind of pathologies in comparison to other standard imaging modalities.
To evaluate the accuracy of WB-MRI in terms of: -Lymphoma:diameters of lesions will be assessed.
Time frame: 36 months
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to other standard methodologies and to assess different patterns of response, stable disease, and progression that can be observed on WB-MRI.
Pattern of response/progression will be determined in terms of: -Myeloma:Myeloma Response Assessment and Diagnosis System (MY-RADS) criteria will be applied on WB-MRI whereas n.of lesions and lesion uptake Standardized Uptake Value (SUV) variations will be used to evaluate PET-CT response.
Time frame: 36 months
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to other standard methodologies and to assess different patterns of response, stable disease, and progression that can be observed on WB-MRI.
Pattern of response/progression will be determined in terms of: -Metastatic prostate cancer and Metastatic breast cancer: soft tissue response and progression on CT will be assessed according to RECIST 1.1guidelines. Definitions of complete and partial response or progression for bone lesions on CT and/or BS have been adopted from MD Anderson (MDA) criteria for ABC and from Prostate Cancer Working Group3 (PCWG3) for APC.
Time frame: 36 months
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to other standard methodologies and to assess different patterns of response, stable disease, and progression that can be observed on WB-MRI.
Pattern of response/progression will be determined in terms of: -Lymphoma:for Contrast-Enhanced Computed Tomography (CE-CT) and PET-CT Lugano criteria or Lymphoma Response to Immunomodulatory Therapy Criteria criteria will be used
Time frame: 36 months
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to other standard methodologies and to assess different patterns of response, stable disease, and progression that can be observed on WB-MRI.
Pattern of response/progression will be determined in terms of: -Lymphoma:for the diameter evaluation of max 5 lymphnodes or lesion integrated with apparent diffusion coefficient (ADC) evaluation will be applied on WB-MRI.
Time frame: 36 months
To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients.
The number of times a patient treatment's course was changed by clinicians after evidences provided by WB-MRI investigations as per clinical routine.
Time frame: 36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
We will evaluate the discriminating performance of imaging features for differentiating between smouldering multiple myeloma and multiple myeloma.
Time frame: 36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
We will assess the discriminating performance of imaging features for differentiating between invasive lobular carcinoma and invasive ductal carcinoma.
Time frame: 36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
We will examine the discriminating performance of imaging features for distinguishing between the heterogeneous histotype characteristics of lymphoma.
Time frame: 36 months
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