LymphomaONCO-MRINCT06895291
Whole Body MRI in Oncology
An observational study of Lymphoma and Advanced Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Advanced Prostate Cancer, Advanced Breast Cancer
- What is being tested?
- Whole Body-Magnetic Resonance Imaging (WB-MRI)
- How many people
- 1,000 participants
- Where
- 3 sitesItaly
- Study dates
- 26 Oct 2023to Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with MRI-unsafe prostheses and devices.
- Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS - Azienda Ospedaliero-Universitaria di Bologna - Policlinico di S. Orsola
Bologna, BO, 40138
Stefano Brocchi, stefano.brocchi@aosp.bo.it
Stefano Brocchi, MD
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, FC, 47014
Alice Rossi, alice.rossi@irst.emr.it
Alice Rossi, MD
- Not yet recruiting
IRCCS Istituto Europeo di Oncologia S.r.l.
Milan, MI, 20141
Giuseppe Petralia, giuseppe.petralia@ieo.it
Giuseppe Petralia, MD
About this study
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.
Read the 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
- Being tested
- Whole Body-Magnetic Resonance Imaging (WB-MRI)
- Keywords
- Monoclonal Gammopathy of Undetermined Significance, Smoldering multiple myeloma, Multiple myeloma, Advanced Breast Cancer, Advanced Prostate Cancer, Lymphoma, Whole Body-Magnetic Resonance Imaging
- Medical subject headings
- Lymphoma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by Monoclonal plasma cell disorders | Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM). Receives: Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI) | |
| 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)). Receives: Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI) | |
| Patients affected by Lymphomas. | Patients affected by Lymphomas. Receives: Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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
Measured: 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.
To evaluate the accuracy of WB-MRI in terms of:
-Lymphoma:number of lesions will be assessed.
Measured: 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.
To evaluate the accuracy of WB-MRI in terms of:
-Lymphoma:diameters of lesions will be assessed.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 36 months
To evaluate how WB-MRI, added to other imaging modalities, alters decision making and management of patients.
The number of times a patient treatment's course was changed by clinicians after evidences provided by WB-MRI investigations as per clinical routine.
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 36 months
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.
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start26 Oct 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Rossi, Principal investigator, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895291
- Sponsor's protocol ID
- IRST100.61
- Acronym
- ONCO-MRI
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body MRI in Oncology
- ClinicalTrials.gov ID
- NCT06895291
- Acronym / sponsor ID
- ONCO-MRI / IRST100.61
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients affected by Monoclonal plasma cell disorders | – | Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM). |
| Patients affected by advanced prostate cancer (APC) or advanced breast cancer (ABC) | – | Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)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)). |
| Patients affected by Lymphomas. | – | Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)Patients affected by Lymphomas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with MRI-unsafe prostheses and devices.
- Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patients affected by Lymphomas., Patients affected by Monoclonal plasma cell disorders, Patients affected by advanced prostate cancer (APC) or advanced breast cancer (ABC) |
Primary outcome
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)
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
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.
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.
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.
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.
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
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.
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.
3 secondary outcomes
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time frame: 36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time frame: 36 months
Identification of imaging biomarkers for precise disease differentiation or for response prediction.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Rossi principal investigator
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Advanced Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriana Nanni (+390543739266, cc.ubsc@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 36 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.