Whole Body MRI in Oncology (ONCO-MRI)

March 25, 2025 updated by: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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) .

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • IRCCS - Azienda Ospedaliero-Universitaria di Bologna - Policlinico di S. Orsola
        • Contact:
        • Principal Investigator:
          • Stefano Brocchi, MD
    • FC
      • Meldola, FC, Italy, 47014
        • Recruiting
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
        • Contact:
        • Principal Investigator:
          • Alice Rossi, MD
    • MI
      • Milano, MI, Italy, 20141
        • Not yet recruiting
        • IRCCS Istituto Europeo di Oncologia S.r.l.
        • Principal Investigator:
          • Giuseppe Petralia, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients affected by Monoclonal plasma cell disorders
Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM).
Diagnostic test: 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.
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)).
Diagnostic test: 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.
Patients affected by Lymphomas.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients.
Time Frame: 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.
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.
Time Frame: 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)
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.
Time Frame: 36 months

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
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.
Time Frame: 36 months

To evaluate the accuracy of WB-MRI in terms of:

-Lymphoma:number of lesions will be assessed.
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.
Time Frame: 36 months

To evaluate the accuracy of WB-MRI in terms of:

-Lymphoma:diameters of lesions will be assessed.
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.
Time Frame: 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.
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.
Time Frame: 36 months

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.
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.
Time Frame: 36 months

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
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.
Time Frame: 36 months

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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time Frame: 36 months
We will evaluate the discriminating performance of imaging features for differentiating between smouldering multiple myeloma and multiple myeloma.
36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time Frame: 36 months
We will assess the discriminating performance of imaging features for differentiating between invasive lobular carcinoma and invasive ductal carcinoma.
36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time Frame: 36 months
We will examine the discriminating performance of imaging features for distinguishing between the heterogeneous histotype characteristics of lymphoma.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alice Rossi, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRST100.61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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