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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different CT imaging techniques for measuring bone marrow in multiple myeloma — could you explain how PET-enabled dual-energy CT differs from standard X-ray dual-energy CT, and why that comparison might matter for how my disease is monitored?
2Since this trial is listed as 'not yet recruiting,' how soon is it expected to open, and would it be worth checking back with you when enrollment begins to see if it might be a good fit for my situation?
3The trial seems focused on measuring and validating an imaging method rather than testing a new treatment — does that mean participating wouldn't change my actual treatment plan, and what would my involvement look like day-to-day?
4Because this study doesn't appear to have a specific phase listed and is primarily evaluating an imaging tool, what does that tell us about whether the goal is to improve how myeloma is detected or tracked rather than to test a therapy?
5Are there any standard imaging or monitoring approaches I should be pursuing right now while this trial is still not yet open, so we don't delay important information about my disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions
Timeframe: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation