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

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

WBMRI

Positron Emission Tomography/Computed Tomography (PET/CT)

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring magnetic resonance imaging, positron emission tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple Myeloma Patients

Arm Description

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).

Outcomes

Primary Outcome Measures

Detection of lesions

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

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.

Progression Free Survival (PFS)

Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with PFS.

Overall Survival (OS)

Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with OS.

Secondary Outcome Measures

Full Information

NCT ID

NCT04493411

First Posted

July 23, 2020

Last Updated

September 25, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04493411

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

magnetic resonance imaging, positron emission tomography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multiple Myeloma Patients

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

WBMRI

Intervention Description

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. Baseline: (before or after 1-2 cycles of induction therapy) Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) Between Week 24 - 36 (before starting maintenance therapy) Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography/Computed Tomography (PET/CT)

Intervention Description

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. Baseline: (before or after 1-2 cycles of induction therapy) Between Week 12 - 24 (before Bone Marrow Transplant or undergoing consolidation therapy) Between Week 24 - 36 (before starting maintenance therapy) Between Week 60 - 72 (post bone marrow transplant or consolidation therapy and after approximately 9 months of maintenance therapy)

Primary Outcome Measure Information:

Title

Detection of lesions

Description

Time Frame

Up to 4 years

Title

Assessment of therapy response

Description

Time Frame

Up to 4 years

Title

Progression Free Survival (PFS)

Description

Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with PFS.

Time Frame

Up to 4 years

Title

Overall Survival (OS)

Description

Will determine if WBMRI prognosis is at baseline, after 4-6 weeks of induction therapy, and before maintenance therapy is associated with OS.

Time Frame

Up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelli Key, PhD

Phone

214-648-8152

Kelli.Key@UTSouthwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ananth Madhuranthakam, PhD

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelli Key, PhD

Phone

214-648-8152

Kelli.Key@UTSouthwestern.edu

First Name & Middle Initial & Last Name & Degree

Ananth Madhuranthakam, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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