Noninvasive Detection and Assessment of Therapy Response in Multiple Myeloma Using Whole-Body MRI

Not Applicable

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Procedure: WBMRI; Procedure: Positron Emission Tomography/Computed Tomography (PET/CT)

• Registration Number: NCT04493411
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Whole body magnetic resonance imaging (WBMRI) will be evaluated for detection and assessment of therapy response in multiple myeloma (MM) using a novel acquisition scheme. WBMRI with diffusion weighted imaging (DWI) has demonstrated promising preliminary results for detection and response monitoring in MM. While DWI generates high lesion-to-background contrast and excellent lesion conspicuity, it suffers from compromised image quality due to geometric distortion, particularly at 3 Tesla magnetic resonance imaging (MRI), a platform which is increasingly used in clinical practice. This disadvantage, along with high costs and patient dissatisfaction associated with long scan times, have limited wide spread adoption of WBMRI with DWI in the clinical practice.

To overcome these challenges, the investigators have developed an alternative WBMRI technique: Dual-Echo T2-weighted acquisition for Enhanced Conspicuity of Tumors (DETECT) for improved tumor visualization by simultaneously suppressing the confounding signals of fat and fluid throughout the body.

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Study Start: 2020-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with pathologically confirmed myeloma.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
• For cross-sectional study, no additional required treatment schedule. For longitudinal study: Patients scheduled to undergo bone marrow biopsy (BMB) and induction therapy (or have gone through 1-2 cycles of induction therapy), followed by either bone marrow transplantation (BMT) or consolidation therapy.
• Women of child-bearing potential must agree to undergo a urine pregnancy screening to prevent imaging of pregnant patients. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
• Subjects must not be pregnant or nursing; since pregnancy is a contraindication to administration of gadolinium-based contrast agents. Furthermore, there is a potential for congenital abnormalities and the potential to harm nursing infants, associated with FDG-PET.
• Any contraindication to MRI per Radiology Department's routine protocol, e.g. MRI-incompatible objects, including but not limited to medical devices and other foreign bodies.
• Known severe allergic reaction to Gadolinium-based contrast agents.
• Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma Patients	WBMRI	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).
Multiple Myeloma Patients	Positron Emission Tomography/Computed Tomography (PET/CT)	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).

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to 4 years	Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with PFS.
Detection of lesions	Up to 4 years	Effectiveness of WBMRI DETECT for the detection of lesions in MM patients will be compared to WBMRI Diffusion Weighted Imaging (DWI). A combination of clinical MRI, whole body x-ray, FDG PET, and bone marrow biopsy will be used as the reference standard.; The number of lesions identified on WBMRI-DETECT will be compared to the number of lesions identified on WBMRI-DWI. The sensitivity and specificity of WBMRI-DETECT and WBMRI-DWI will be calculated using the reference standard.
Assessment of therapy response	Up to 4 years	Effectiveness of WBMRI for assessing therapy response will be compared to the current standard of care using FDG PET and bone marrow biopsy as the validation standard.; The percentage increase in fat fraction measured using WBMRI-DETECT and the percentage increase in apparent diffusion coefficient (ADC) measured using WBMRI-DWI will be used to assess the effectiveness of WBMRI in measuring therapy response. The percentage change in SUVmax measured on PET/CT will be used as the reference standard.
Overall Survival (OS)	Up to 4 years	Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with OS.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States