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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to prospectively determine the sensitivity, specificity, and diagnostic accuracy of whole-body MRI (WBMRI) with Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for the detection of multiple myeloma. Subjects will undergo WBMRI and fluorodeoxyglucose (FDG) positron emission tomography (PET) for research purposes either at one time point for cross-sectional study or at four time points for longitudinal study: baseline, prior to bone marrow transplant (BMT), prior to maintenance therapy, and post BMT. The results of these imaging procedures will be compared to standard of care whole body x-ray and bone marrow biopsy results.

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 data supports the effectiveness of the treatment Whole-Body MRI for Multiple Myeloma?

Research shows that whole-body MRI (WBMRI) and PET/CT scans are both effective in diagnosing and managing multiple myeloma, with studies comparing their performance in determining remission status and initial staging. These imaging techniques help doctors see how well the treatment is working and guide further management of the disease. ^{1 2 3 4 5}

Is whole-body MRI with gadolinium-based contrast agents safe for humans?

Gadolinium-based contrast agents (GBCAs) used in MRI are generally safe, but they can have side effects like allergic reactions and a rare condition called nephrogenic systemic fibrosis (NSF) in people with kidney problems. Gadolinium can also deposit in the body, but no harmful effects have been found from this deposition in people with normal kidney function. ^{6 7 8 9 10}

How does whole-body MRI differ from other treatments for multiple myeloma?

Whole-body MRI is unique because it provides a comprehensive imaging technique to assess multiple myeloma, offering detailed insights into the disease's spread and remission status without using radiation, unlike PET/CT scans. It is particularly useful for detecting incidental findings and optimizing treatment management. ^{1 2 3 4 11}

Research Team

Avneesh Chhabra, MD, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparative diagnostic performance of ¹⁸F-FDG PET/CT versus whole-body MRI for determination of remission status in multiple myeloma after stem cell transplantation. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the diagnostic performance and impact on management of 18F-FDG PET/CT and whole-body MRI in multiple myeloma. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of whole body magnetic resonance imaging (WBMRI) to whole body computed tomography (WBCT) or 18F-fluorodeoxyglucose positron emission tomography/CT (18F-FDG PET/CT) in patients with myeloma: Systematic review of diagnostic performance. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Whole body MRI in multiple myeloma: Optimising image acquisition and read times. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Agreement Between 18F-FDG PET/CT and Whole-Body Magnetic Resonance Compared With Skeletal Survey for Initial Staging and Response at End-of-Treatment Evaluation of Patients With Multiple Myeloma. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Update on Gadolinium Based Contrast Agent Safety, From the AJR Special Series on Contrast Media. [2023]

7. United States 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. [2016]

8. United States 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. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]

10. Germany 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. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Added Value of Contrast-Enhanced T1-Weighted and Diffusion-Weighted Sequences for Characterization of Incidental Findings on Whole Body Magnetic Resonance Imaging in Plasma-Cell Disorders. [2019]