Advanced Breast Cancer, Advanced Prostate Cancer, Lymphoma, Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
Conditions
Keywords
Monoclonal Gammopathy of Undetermined Significance, Smoldering multiple myeloma, Multiple myeloma, Advanced Breast Cancer, Advanced Prostate Cancer, Lymphoma, Whole Body-Magnetic Resonance Imaging
Brief summary
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.
Detailed description
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) .
Interventions
DIAGNOSTIC_TESTWhole Body-Magnetic Resonance Imaging (WB-MRI)
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.
Sponsors
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above. * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged ≥ 18 years. * Life expectancy greater than 3 months.
Exclusion criteria
* Patients with MRI-unsafe prostheses and devices. * Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 36 months | 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) |
| 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. | 36 months | 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. |
| To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients. | 36 months | The number of times a patient treatment's course was changed by clinicians after evidences provided by WB-MRI investigations as per clinical routine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of imaging biomarkers for precise disease differentiation or for response prediction. | 36 months | We will evaluate the discriminating performance of imaging features for differentiating between smouldering multiple myeloma and multiple myeloma. |
Countries
Italy
Contacts
Primary ContactOriana Nanni
Backup ContactBernadette Vertogen
Outcome results
None listed