Whole Body MRI in Oncology (ONCO-MRI)

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Status: Enrolling

Conditions: Multiple Myeloma; Advanced Prostate Cancer; Lymphoma; Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Advanced Breast Cancer

Treatments: Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)

Study type: Observational

Funder types: Other

Identifiers

NCT06895291

IRST100.61

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

Patients affected by Monoclonal plasma cell disorders

Description:

Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM).

Treatment:

Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)

Patients affected by advanced prostate cancer (APC) or advanced breast cancer (ABC)

Description:

Patients affected by advanced prostate (APC) or breast cancer (ABC) with high suspicious of metastasis particularly in case of diagnostic doubt in other imaging methods (Computed tomography (CT), Positron Emission Computed Tomography (PET/CT), Bone Scintigraphy (BS)).

Treatment:

Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)

Patients affected by Lymphomas.

Description:

Patients affected by Lymphomas.

Treatment:

Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)