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NCT Number: NCT06895291

Whole Body MRI in Oncology

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.

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Key information

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Body-Magnetic Resonance Imaging (WB-MRI)

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bernadette Vertogen

CONTACT

[email protected]

+390544286058

Oriana Nanni

CONTACT

[email protected]

+390543739266

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: ONCO-MRI

Important dates

Study start
2023
Primary completion
2028
Study completion
2031
First posted
Mar 26, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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