PET-Enabled Dual-Energy CT in Multiple Myeloma

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07646873
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PET-enabled dual-energy CT imaging — DIAGNOSTIC_TEST
    18F-FDG will be administered intravenously for dynamic PET/CT imaging.
  • X-ray dual-energy CT imaging — DIAGNOSTIC_TEST
    Participants will undergo X-ray dual-energy CT imaging. Measurements from X-ray dual-energy CT will be used as the reference method for comparison with PET-enabled dual-energy CT measurements.

Study Details

This pilot study will evaluate a new imaging method called PET-enabled dual-energy CT for measuring bone and soft-tissue composition in bone marrow. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants. All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray dual-energy CT. Participants with multiple myeloma will have imaging before CAR T-cell therapy and again after therapy. Healthy participants will have one imaging visit. The main goal is to compare bone and soft-tissue fraction measurements from PET-enabled dual-energy CT with measurements from standard X-ray dual-energy CT. The study will also explore whether corrected PET measurements are associated with bone marrow measurable residual disease, treatment response, and CAR T-cell therapy toxicities in participants with multiple myeloma. This study is not expected to provide direct medical benefit to participants. The information learned may help improve future PET/CT imaging methods for cancer evaluation.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Multiple Myeloma Participants
    Adults with multiple myeloma who are scheduled to receive CAR T-cell therapy. Participants will undergo baseline dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging before CAR T-cell therapy. Participants will also undergo follow-up dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging after CAR T-cell therapy.
  • Experimental: Healthy Participants
    Healthy adult participants without a history of cardiovascular, inflammatory, infectious, or metabolic diseases expected to affect bone marrow. Participants will undergo one dynamic 18F-FDG PET/CT and X-ray dual-energy CT imaging visit.

Primary Outcome Measure

Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions [ Time Frame: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis EXPLORER Molecular Imaging CenterSacramentoCalifornia95816
Clinical Research Coordinator Team
[email protected]
916-731-9004
Guobao Wang, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
UC Davis EXPLORER Molecular Imaging Center· Sacramento, CA

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