Status:
TERMINATED
Noninvasive Detection and Assessment of Therapy Response in Multiple Myeloma Using Whole-Body MRI
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
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 Tum...
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 weighte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04493411
Start Date
November 30 2020
End Date
April 12 2024
Last Update
July 24 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390