NCT04493411

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	WBMRI	WBMRI will be performed either at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points. 1. Baseline: (before or after 1-2 cycles of induction therapy) 2. Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) 3. Between Week 24 - 36 (before starting maintenance therapy) 4. Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)
PROCEDURE	Positron Emission Tomography/Computed Tomography (PET/CT)	PET/CT will be performed at at 1 time point for cross-sectional study or at 4 timepoints for the longitudinal study at the following time points. 1. Baseline: (before or after 1-2 cycles of induction therapy) 2. Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) 3. Between Week 24 - 36 (before starting maintenance therapy) 4. Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)

Timeline

• Start date: 2020-11-30
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2020-07-30
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States