A new type of scan to study bone marrow in multiple myeloma

Trial details

Who runs it

University of California, Davis

Trial code

NCT07646873

Record updated

15 June 2026

Original description

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.Read full original descriptionShow less

PET-enabled Dual-energy CT for Oncological Applications

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.

Inclusion: 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.

Exclusion: 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); 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; Self-reported history of dysphoria or anxiety in closed spaces; Any condition that would prevent the understanding or rendering of informed consent; Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG; Body weight >240 kg due to limitations of the scanner bed; Prisoners; Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.

ClinicalTrials.gov NCT07646873