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

NCT ID: NCT04493411

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2024-04-12

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Multiple Myeloma Patients

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).

Group Type: EXPERIMENTAL

WBMRI

Intervention Type: PROCEDURE

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)

Positron Emission Tomography/Computed Tomography (PET/CT)

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Avneesh Chhabra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avneesh Chhabra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2019-0834

Identifier Type: -

Identifier Source: org_study_id