Whole-Body MRI for Multiple Myeloma

Overseen By Kelli Key, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Uncontrolled illness, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of whole-body MRI scans in detecting multiple myeloma, a type of blood cancer. Researchers will compare MRI results with other tests, such as PET scans (Positron Emission Tomography) and bone marrow biopsies. The trial includes individuals diagnosed with multiple myeloma who are either about to begin treatment or have completed 1-2 treatment cycles. Participants will undergo either a single scan or multiple scans over time to monitor their response to treatment. As an unphased trial, this study allows participants to contribute to the advancement of diagnostic methods for multiple myeloma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be on any other investigational cancer treatments while participating in this study.

What prior data suggests that whole-body MRI is safe for detecting multiple myeloma?

Research has shown that whole-body MRI (WBMRI) is a comfortable and safe imaging method for diagnosing diseases like multiple myeloma. Unlike some other imaging tests, WBMRI does not use radiation, making it suitable for repeated use if necessary. No serious side effects have been reported from WBMRI in patients with multiple myeloma.

The trial also includes PET scans, which use a small amount of radioactive material to assess body function. Although PET scans involve radiation, they are generally safe. Most people do not experience issues, though some might feel mild discomfort from the injection.

Overall, both WBMRI and PET scans are safe for humans and have been used in medical settings for many years. Participants in this trial can expect these procedures to be well-tolerated based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whole-body MRI (WBMRI) for multiple myeloma because it offers a comprehensive view of the entire skeleton without radiation exposure, unlike standard imaging methods like X-rays or CT scans. WBMRI can detect smaller lesions that might be missed by traditional methods, potentially leading to earlier and more accurate assessments of disease spread. This can be particularly beneficial in tracking therapy response over time, offering a safer and more detailed alternative to current imaging techniques.

What evidence suggests that WBMRI is effective for detecting multiple myeloma?

Research has shown that whole-body MRI (WBMRI) effectively detects multiple myeloma. Studies have found it more accurate than PET scans in identifying active disease. WBMRI reliably finds active myeloma and can detect more areas where cancer is present. It also helps predict the likelihood of cancer returning and provides insight into patient survival. These findings suggest that WBMRI is a promising tool for diagnosing and monitoring multiple myeloma. ^{2 6 7 8 9}

Who Is on the Research Team?

Avneesh Chhabra, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with confirmed multiple myeloma who can consent to the study. They must have a performance status allowing daily activity (ECOG 0-2). Women able to bear children must test negative for pregnancy. Participants should not be on other investigational treatments, pregnant, or nursing and should not have severe illnesses or conditions that MRI cannot accommodate.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

I am scheduled for or have started induction therapy and will have a bone marrow biopsy, followed by transplantation or consolidation therapy.

I am a woman who can become pregnant and agree to a pregnancy test before imaging.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Subjects may not be receiving any other investigational agents for the treatment of the cancer under study

You have a condition that makes it unsafe for you to have an MRI scan according to the hospital's rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline whole-body MRI and FDG PET imaging for initial assessment

1 week

1 visit (in-person)

Induction Therapy Monitoring

Participants are monitored with imaging prior to bone marrow transplant and maintenance therapy

4-6 weeks

2 visits (in-person)

Post-Transplant Imaging

Participants undergo imaging post bone marrow transplant to assess therapy response

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Positron Emission Tomography/Computed Tomography (PET/CT)
• WBMRI

Trial Overview The study tests how well whole-body MRI detects multiple myeloma compared to standard x-rays and bone marrow biopsies. It involves one-time imaging for some participants or four sessions over time—before and after bone marrow transplant or maintenance therapy—for others.

How Is the Trial Designed?

Group I: Multiple Myeloma Patients Experimental Treatment 2 Interventions

Patients with pathologically confirmed myeloma for cross-sectional study (detection) or scheduled to undergo induction therapy (or have gone 1-2 cycles of induction therapy), followed by either bone marrow transplantation or consolidation therapy for longitudinal study (therapy response assessment).

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Gadolinium-based contrast agents (GBCAs) are generally very safe for use in MRI, with acute allergic reactions being rare and less common than those associated with iodinated contrast agents.

While there are concerns about gadolinium deposition in the brain and other organs, current evidence shows no adverse biological or clinical effects from this retention, especially in patients with normal kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. Starekova, J., Pirasteh, A., Reeder, SB.[2023]

In a study involving 17,767 patients across 45 European centers, only 30 acute adverse reactions (0.17%) were reported after administering gadolinium-based contrast agents during cardiac magnetic resonance imaging, all classified as mild.

The most common reactions included rashes, hives, nausea, and anxiety, with the incidence of adverse events being comparable to that seen in general radiology settings, indicating that the off-label use of these agents in CMR is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. Bruder, O., Schneider, S., Nothnagel, D., et al.[2016]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

In a study of 154,779 patients undergoing cardiac MRI, gadolinium-based contrast agents (GBCAs) were used in 94.2% of cases, with a significant shift towards macrocyclic agents following regulatory changes, which showed a favorable acute safety profile.

The overall rate of acute adverse events (AAEs) associated with GBCAs was low at 0.36%, with severe events occurring in only 0.03% of patients, indicating that GBCAs, particularly macrocyclic types, are generally safe for use in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. Uhlig, J., Al-Bourini, O., Salgado, R., et al.[2022]

Gadolinium-based contrast agents (GBCAs) have a strong safety record in MRI imaging, but there are known risks such as acute adverse reactions and nephrogenic systemic fibrosis that require ongoing management and understanding.

The review highlights that certain populations, including those with kidney issues, are at higher risk for complications from GBCAs, and it also discusses the emerging use of ferumoxytol as a non-GBCA alternative with its own risk profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. Ponrartana, S., Moore, MM., Chan, SS., et al.[2021]

Citations

1. nature.com nature.com/articles/s41408-025-01327-4

Whole body MRI by MY-RADS for imaging response ... Our results support WB-MRI implementation for evaluation of residual disease alongside conventional laboratory-based assessments.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6992198/

Whole body MRI in multiple myeloma: Optimising image ... Observers detected more myeloma lesions on DWI images and WOC images when compared to other image types. We suggest that these image types ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.08.1633

Whole-Body MRI Versus PET in Assessment of Multiple ... Whole-body MRI performed better than PET in the assessment of disease activity, having a higher sensitivity and specificity.

4. royalmarsden.nhs.uk royalmarsden.nhs.uk/news-and-events/news/royal-marsden-led-study-finds-whole-body-mri-scan-can-predict-relapse-and

Royal Marsden led study finds whole-body MRI scan can ... Royal Marsden led study finds whole-body MRI scan can predict relapse and survival in multiple myeloma patients. Whole-body MRI scans provide ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.8012

Prospective comparison of whole body MRI and FDG PET ... WB MRI increases detection of focal and diffuse disease compared with FDG PET/CT, including improved detection of focal lesions meeting criteria for active ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8626374/

Whole-body magnetic resonance imaging (WBMRI) versus ... This review addresses the current improvements and limitations of WBCT and WBMRI for diagnosis and staging in MM, underlining the fact that both modalities ...

7. myeloma.org myeloma.org/imwg/role-magnetic-resonance-imaging-management

IMWG Role of MRI for MM patients| Int'l Myeloma Fndn For smoldering or asymptomatic myeloma, all patients should undergo whole-body MRI (WB-MRI) or spine and pelvic MRI if WB-MRI is not available. ​; The ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0009926021002087

Whole-body MRI: a practical guide for imaging patients ... Whole-body magnetic resonance imaging (MRI) is now a crucial tool for the assessment of the extent of systemic malignant bone disease and response to treatment.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8519652/

What's New for Clinical Whole-body MRI (WB-MRI) in the ... Current consensus reporting criteria include MET-RADS-P for advanced prostate cancer, MY-RADS for multiple myeloma and Whole-Body Score for Inflammation in ...