Clinical trial NCT06895291: Whole Body MRI in Oncology
Official title: Whole Body MRI in Oncology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Advanced Prostate Cancer
Advanced Breast Cancer
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Multiple Myeloma
Keywords: Monoclonal Gammopathy of Undetermined Significance
Smoldering multiple myeloma
Multiple myeloma
Advanced Breast Cancer
Advanced Prostate Cancer
Lymphoma
Whole Body-Magnetic Resonance Imaging
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The following patients groups will be prospectively enrolled:

* Patients affected by Monoclonal plasma cell disorders (monoclonal gammopathy of undertermined significance-MGUS, Smoldering multiple myeloma- SMM, Multiple myeloma-MM).
* 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 (CT, PET/CT, BS).
* Patients affected by Lymphomas.

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) .

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: 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.
timeFrame: 36 months
measure: To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients.
timeFrame: 36 months
Secondary outcomes:
measure: Identification of imaging biomarkers for precise disease differentiation or for response prediction.
timeFrame: 36 months
measure: Identification of imaging biomarkers for precise disease differentiation or for response prediction.
timeFrame: 36 months
measure: Identification of imaging biomarkers for precise disease differentiation or for response prediction.
timeFrame: 36 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Azienda Ospedaliero-Universitaria di Bologna - Policlinico di S. Orsola
state: BO
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
state: FC
city: Milano
country: Italy
facility: IRCCS Istituto Europeo di Oncologia S.r.l.
state: MI
Study officials:
affiliation: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
name: Alice Rossi
role: PRINCIPAL_INVESTIGATOR
References: