Whole Body MRI in Oncology

NCT ID: NCT06895291

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2031-10-31

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) .

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients affected by Monoclonal plasma cell disorders

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

Whole Body-Magnetic Resonance Imaging (WB-MRI)

Intervention Type: DIAGNOSTIC_TEST

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.

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

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)).

Whole Body-Magnetic Resonance Imaging (WB-MRI)

Intervention Type: DIAGNOSTIC_TEST

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.

Patients affected by Lymphomas.

Patients affected by Lymphomas.

Whole Body-Magnetic Resonance Imaging (WB-MRI)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Whole 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice Rossi

Role: PRINCIPAL_INVESTIGATOR

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

Locations

IRCCS - Azienda Ospedaliero-Universitaria di Bologna - Policlinico di S. Orsola

Bologna, BO, Italy

Site Status: RECRUITING

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

Meldola, FC, Italy

Site Status: RECRUITING

IRCCS Istituto Europeo di Oncologia S.r.l.

Milan, MI, Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Oriana Nanni

Role: CONTACT

cc.ubsc@irst.emr.it

+390543739266

Bernadette Vertogen

Role: CONTACT

cc.ubsc@irst.emr.it

+390544286058

Facility Contacts

Stefano Brocchi

Role: primary

stefano.brocchi@aosp.bo.it

Alice Rossi

Role: primary

alice.rossi@irst.emr.it

Giuseppe Petralia

Role: primary

giuseppe.petralia@ieo.it

Other Identifiers

IRST100.61

Identifier Type: -

Identifier Source: org_study_id