Whole Body MRI in Oncology

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with MRI-unsafe prostheses and devices.

Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Patients affected by Monoclonal plasma cell disorders1 intervention
Group B: Patients affected by advanced prostate cancer (APC) or advanced breast cancer (ABC)1 intervention
Group C: Patients affected by Lymphomas.1 intervention

Trial outcomes

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.

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)

Time frame
36 months
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.

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

Time frame
36 months
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.

To evaluate the accuracy of WB-MRI in terms of: -Lymphoma:number of lesions will be assessed.

Time frame
36 months
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.

To evaluate the accuracy of WB-MRI in terms of: -Lymphoma:diameters of lesions will be assessed.

Time frame
36 months

Secondary outcomes

1

Identification of imaging biomarkers for precise disease differentiation or for response prediction.

We will evaluate the discriminating performance of imaging features for differentiating between smouldering multiple myeloma and multiple myeloma.

Time frame
36 months
2

Identification of imaging biomarkers for precise disease differentiation or for response prediction.

We will assess the discriminating performance of imaging features for differentiating between invasive lobular carcinoma and invasive ductal carcinoma.

Time frame
36 months
3

Identification of imaging biomarkers for precise disease differentiation or for response prediction.

We will examine the discriminating performance of imaging features for distinguishing between the heterogeneous histotype characteristics of lymphoma.

Time frame
36 months

Other outcomes

Sponsors and contacts

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