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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PET-enabled dual-energy CT imaging

    Diagnostic test

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

  • 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.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Multiple Myeloma ParticipantsExperimental treatment 2 interventions
Group B: Healthy ParticipantsExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline imaging visit
2

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.

Time frame
Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
3

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.

Time frame
Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: