PET-Enabled Dual-Energy CT in Multiple Myeloma

ConditionMultiple Myeloma (MM)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Davis

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

PET-enabled dual-energy CT imaging
X-ray dual-energy CT imaging

Treatment groups

45 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of California, Davis

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov