Clinical trial · Interventional
PET-Enabled Dual-Energy CT in Multiple Myeloma
PET-enabled Dual-energy CT for Oncological Applications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-enabled dual-energy CT imaging | Diagnostic Test | — | UNRESOLVED |
| X-ray dual-energy CT imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multiple Myeloma Participants
- description
- 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.
- interventionNames
- Diagnostic Test: PET-enabled dual-energy CT imaging
- Diagnostic Test: X-ray dual-energy CT imaging
- type
- EXPERIMENTAL
- label
- Healthy Participants
- description
- 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.
- interventionNames
- Diagnostic Test: PET-enabled dual-energy CT imaging
- Diagnostic Test: X-ray dual-energy CT imaging
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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.
References
Publications (0)
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