PET-Enabled Dual-Energy CT in Multiple Myeloma

NCT07646873 | Not Yet Recruiting

• 2 other identifiers: 23994111R01EB036562-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma (MM)

Keywords

PET-enabled dual-energy CT; Dual-energy CT; PET/CT; 18F-FDG; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions

  Agreement between PET-enabled dual-energy CT and standard X-ray dual-energy CT will be assessed for quantitative bone fraction and soft-tissue fraction measurements in bone marrow regions.

  Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation

Secondary Outcomes (4)

• Difference in bone marrow bone fraction between multiple myeloma participants and healthy participants

  Baseline imaging visit

• Corrected 18F-FDG standardized uptake value in bone marrow

  Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation

• Association between corrected PET measures and bone marrow measurable residual disease

  Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation

• Association between corrected PET measures and CAR T-cell therapy response and toxicities

  Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation

Study Arms (2)

Multiple Myeloma Participants

EXPERIMENTAL

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.

Diagnostic Test: PET-enabled dual-energy CT imaging; Diagnostic Test: X-ray dual-energy CT imaging

Healthy Participants

EXPERIMENTAL

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.

Diagnostic Test: PET-enabled dual-energy CT imaging; Diagnostic Test: X-ray dual-energy CT imaging

Interventions

PET-enabled dual-energy CT imaging DIAGNOSTIC_TEST

18F-FDG will be administered intravenously for dynamic PET/CT imaging.

Healthy Participants; Multiple Myeloma Participants

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.

Healthy Participants; Multiple Myeloma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all research participants:
• Adults (age ≥ 18 years old)
• Ability to understand and willingness to sign an informed consent form
• Ability to adhere to the study visit schedule and other protocol requirements.
• Willing and able to fast for at least 6 hours before and for the duration of the scan
• No strenuous exercise for 24 hours prior to being scanned
• Willing to lie on the scanner bed for up to 60 minutes
• For healthy volunteers only:
• Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in bone marrow.
• For cancer patients only:
• Patients with multiple myeloma who are planned to receive CAR T-cell therapy with any FDA-approved product, including Idecel and Ciltacel. Patients with prior chemo-immunotherapy are permitted.
• Able to undergo bone marrow aspirate/biopsy procedure

You may not qualify if:

• Self-reported history of dysphoria or anxiety in closed spaces
• Body weight \>240 kg due to limitations of the scanner bed
• Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)
• Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG
• Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.
• Prisoners
• Any condition that would prevent the understanding or rendering of informed consent.
• Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

UC Davis EXPLORER Molecular Imaging Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Guobao Wang, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator Team

CONTACT

916-731-9004; research-radiology-som@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (1)