Multiple Myeloma (MM)NCT07646873
PET-Enabled Dual-Energy CT in Multiple Myeloma
A study testing PET-enabled dual-energy CT imaging and X-ray dual-energy CT imaging in people with Multiple Myeloma (MM), run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma (MM)
- What is being tested?
- PET-enabled dual-energy CT imaging and X-ray dual-energy CT imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816
Clinical Research Coordinator Team, 916-731-9004, research-radiology-som@health.ucdavis.edu
Guobao Wang, PhD
About this study
Official title: 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.
Read more
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.
Read the detailed description
This is a single-institution, prospective pilot study evaluating PET-enabled dual-energy CT (DECT) for quantitative bone marrow imaging. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants for comparison.
PET-enabled DECT is an imaging method that uses data from a standard time-of-flight PET/CT scan to generate a high-energy attenuation image. This image is combined with the standard X-ray CT image to create a dual-energy image pair. The goal is to measure tissue composition, including bone fraction and soft-tissue fraction, without requiring dedicated dual-energy PET/CT hardware.
All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray DECT. Participants with multiple myeloma will undergo baseline imaging before CAR T-cell therapy and follow-up imaging after therapy. Healthy participants will undergo one imaging visit. Multiple myeloma participants will also have bone marrow measurable residual disease (MRD), treatment response, and CAR T-cell therapy toxicity data collected from standard clinical care or related clinical assessments.
The primary objective is to develop and validate the new DECT method for quantitatively measuring tissue compositions of bone marrow regions in multiple myeloma and healthy participants using X-ray DECT as the reference. Secondary objectives include: To determine whether bone fraction in bone marrow differs between MM patients and healthy participants and whether PET-enabled DECT can accurately estimate bone fraction for correcting PET-based bone-marrow metabolic measurements; and, to evaluate relationships between corrected PET measures and bone marrow MRD and treatment response and toxicities of CAR T-cell therapy in MM patients This study is exploratory and is designed to collect preliminary data to support future larger studies. The research imaging is not intended to guide clinical care, and participants are not expected to receive direct medical benefit from participation. The information learned may help improve quantitative PET/CT imaging methods for future cancer evaluation and treatment monitoring.
- Conditions
- Multiple Myeloma (MM)
- Being tested
- PET-enabled dual-energy CT imaging, X-ray dual-energy CT imaging
- Keywords
- PET-enabled dual-energy CT, Dual-energy CT, PET/CT, 18F-FDG, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-enabled dual-energy CT imagingDiagnostic test
18F-FDG will be administered intravenously for dynamic PET/CT imaging.
X-ray dual-energy CT imagingDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: PET-enabled dual-energy CT imaging; Diagnostic Test: X-ray dual-energy CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Bone fraction in bone marrow regions will be compared between participants with multiple myeloma and healthy participants using PET-enabled DECT and X-ray DECT measurements.
Measured: Baseline imaging visit
Corrected 18F-FDG standardized uptake value in bone marrow
Bone marrow 18F-FDG standardized uptake value will be corrected for bone fraction using PET-enabled DECT-derived tissue fraction measurements.
Measured: 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
Corrected PET measures, including corrected standardized uptake value and kinetic parameters, will be evaluated for association with bone marrow measurable residual disease in multiple myeloma participants.
Measured: 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
Corrected PET measures, including corrected bone marrow standardized uptake value and 18F-FDG kinetic parameters, will be evaluated for association with CAR T-cell therapy response and toxicities in participants with multiple myeloma.
Measured: Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Guobao Wang, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646873
- Sponsor's protocol ID
- 2399411
- Other IDs
- 1R01EB036562-01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-enabled Dual-energy CT for Oncological Applications
- ClinicalTrials.gov ID
- NCT07646873
- Acronym / sponsor ID
- 2399411
- Conditions
- Multiple Myeloma (MM)
- Keywords
- PET-enabled dual-energy CT, Dual-energy CT, PET/CT, 18F-FDG, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-institution, prospective pilot study evaluating PET-enabled dual-energy CT (DECT) for quantitative bone marrow imaging. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants for comparison.
PET-enabled DECT is an imaging method that uses data from a standard time-of-flight PET/CT scan to generate a high-energy attenuation image. This image is combined with the standard X-ray CT image to create a dual-energy image pair. The goal is to measure tissue composition, including bone fraction and soft-tissue fraction, without requiring dedicated dual-energy PET/CT hardware.
All participants will undergo research imaging with dynamic 18F-FDG PET/CT and X-ray DECT. Participants with multiple myeloma will undergo baseline imaging before CAR T-cell therapy and follow-up imaging after therapy. Healthy participants will undergo one imaging visit. Multiple myeloma participants will also have bone marrow measurable residual disease (MRD), treatment response, and CAR T-cell therapy toxicity data collected from standard clinical care or related clinical assessments.
The primary objective is to develop and validate the new DECT method for quantitatively measuring tissue compositions of bone marrow regions in multiple myeloma and healthy participants using X-ray DECT as the reference. Secondary objectives include: To determine whether bone fraction in bone marrow differs between MM patients and healthy participants and whether PET-enabled DECT can accurately estimate bone fraction for correcting PET-based bone-marrow metabolic measurements; and, to evaluate relationships between corrected PET measures and bone marrow MRD and treatment response and toxicities of CAR T-cell therapy in MM patients This study is exploratory and is designed to collect preliminary data to support future larger studies. The research imaging is not intended to guide clinical care, and participants are not expected to receive direct medical benefit from participation. The information learned may help improve quantitative PET/CT imaging methods for future cancer evaluation and treatment monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Participants | Experimental | Diagnostic Test: PET-enabled dual-energy CT imaging, Diagnostic Test: X-ray dual-energy CT imagingAdults 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. |
| Healthy Participants | Experimental | Diagnostic Test: PET-enabled dual-energy CT imaging, Diagnostic Test: X-ray dual-energy CT imagingHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-enabled dual-energy CT imaging18F-FDG will be administered intravenously for dynamic PET/CT imaging. | Diagnostic test | Healthy Participants, Multiple Myeloma Participants |
| X-ray dual-energy CT imagingParticipants 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. | Diagnostic test | Healthy Participants, Multiple Myeloma Participants |
Primary outcome
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
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.
4 secondary outcomes
Difference in bone marrow bone fraction between multiple myeloma participants and healthy participants
Time frame: Baseline imaging visit
Corrected 18F-FDG standardized uptake value in bone marrow
Time frame: 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
Time frame: 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
Time frame: Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guobao Wang, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-enabled dual-energy CT imaging and X-ray dual-energy CT imaging in people with Multiple Myeloma (MM), run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator Team (916-731-9004, research-radiology-som@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.