NCT06895291

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
66mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Oct 2023Oct 2031

Study Start

First participant enrolled

October 26, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

March 19, 2025

Last Update Submit

March 25, 2025

Conditions

LymphomaAdvanced Prostate CancerAdvanced Breast CancerMonoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple MyelomaMultiple Myeloma

Keywords

Monoclonal Gammopathy of Undetermined SignificanceSmoldering multiple myelomaMultiple myelomaAdvanced Breast CancerAdvanced Prostate CancerLymphomaWhole Body-Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (9)

  • 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)

    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

    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.

    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.

    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.

    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.

    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

    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.

    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.

    36 months

Secondary Outcomes (3)

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

    36 months

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

    36 months

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

    36 months

Study Arms (3)

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)

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)

Patients affected by Lymphomas.

Patients affected by Lymphomas.

Diagnostic Test: Whole Body-Magnetic Resonance Imaging (WB-MRI)

Interventions

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.

Patients affected by Lymphomas.Patients affected by Monoclonal plasma cell disordersPatients affected by advanced prostate cancer (APC) or advanced breast cancer (ABC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with MRI-unsafe prostheses and devices.
  • Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Bologna, BO, 40138, Italy

RECRUITING

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

Meldola, FC, 47014, Italy

RECRUITING

IRCCS Istituto Europeo di Oncologia S.r.l.

Milan, MI, 20141, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

LymphomaMonoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple MyelomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesParaproteinemiasPrecancerous ConditionsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic Disorders

Study Officials

  • Alice Rossi

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oriana Nanni

CONTACT

+390543739266cc.ubsc@irst.emr.it

Bernadette Vertogen

CONTACT

+390544286058cc.ubsc@irst.emr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 26, 2025

Study Start

October 26, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2031

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)