PET-Enabled Dual-Energy CT in Multiple Myeloma
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Research Coordinator Team
- Número de teléfono: 916-731-9004
- Correo electrónico: research-radiology-som@health.ucdavis.edu
Ubicaciones de estudio
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California
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Sacramento, California, Estados Unidos, 95816
- UC Davis EXPLORER Molecular Imaging Center
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Investigador principal:
- Guobao Wang, PhD
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Contacto:
- Clinical Research Coordinator Team
- Número de teléfono: 916-731-9004
- Correo electrónico: research-radiology-som@health.ucdavis.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Multiple Myeloma Participants
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.
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18F-FDG will be administered intravenously for dynamic PET/CT imaging.
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.
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Experimental: Healthy Participants
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.
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18F-FDG will be administered intravenously for dynamic PET/CT imaging.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Agreement between PET-enabled DECT and X-ray DECT measurements of bone marrow tissue fractions
Periodo de tiempo: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
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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.
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Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in bone marrow bone fraction between multiple myeloma participants and healthy participants
Periodo de tiempo: Baseline imaging visit
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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.
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Baseline imaging visit
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Corrected 18F-FDG standardized uptake value in bone marrow
Periodo de tiempo: Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
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Bone marrow 18F-FDG standardized uptake value will be corrected for bone fraction using PET-enabled DECT-derived tissue fraction measurements.
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Baseline imaging visit; and for multiple myeloma participants, follow-up imaging at approximately Day +90 after CAR T-cell therapy initiation
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Association between corrected PET measures and bone marrow measurable residual disease
Periodo de tiempo: Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
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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.
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Baseline and follow-up assessments through approximately Day +90 after CAR T-cell therapy initiation
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Association between corrected PET measures and CAR T-cell therapy response and toxicities
Periodo de tiempo: Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
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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.
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Baseline imaging through approximately Day +90 after CAR T-cell therapy initiation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guobao Wang, PhD, University of California, Davis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Neoplasias De Células Plasmáticas
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Enfermedades hemic y linfáticas
- Mieloma múltiple
Otros números de identificación del estudio
- 2399411
- 1R01EB036562-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Mieloma múltiple (MM)
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Hecheng Li M.D., Ph.DSecond Affiliated Hospital, School of Medicine, Zhejiang University; Ruijin Hospital y otros colaboradoresTerminadoLa seguridad de la coagulación con bisturí de ultrasonido para vasos sanguíneos con un diámetro mayor a 5 mm y menor o igual a 7 mmPorcelana
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Beijing Normal UniversityTerminadoGrupo MM | Grupo LKCM | Grupo de lista de esperaPorcelana
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Anqing Municipal HospitalReclutamientoDolor de garganta | Tubos traqueales con un diámetro interno de 6.0 mm | Tubos traqueales con un diámetro interno de 6.5 mm | Tubos traqueales con un diámetro interno de 7.0 mmPorcelana
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Unity Health TorontoAún no reclutandoPólipo colorrectal de 10-20 mm
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Universitat Internacional de CatalunyaReclutamientoPacientes parcialmente edéntulos | Cresta ósea de al menos 10 mm de largo y 6 mm de ancho | Pacientes de al menos 18 añosEspaña
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Institute of Hematology & Blood Diseases Hospital...Hebei Taihe Chunyu Biotechnology Co., LtdReclutamientoLeucemia de células plasmáticas | Ultra alto riesgo MM (UHR-MM), 18-70 años, adecuado para ASCT. Y cumplir con cualquiera de las siguientes definiciones de UHR-MM | Citogenética ultra alto riesgo | Refractario primario | Progresión temprana | Infiltración extramedular no paragrosa | R2-ISS-IV /MPSS-IVPorcelana
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Mario BoccadoroTerminado
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Seoul National University HospitalReclutamientoPólipos o masas en la vesícula biliar de más de 8-10 mm de tamañoCorea, república de
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National Taiwan University HospitalReclutamientoPólipo colorrectal pedunculado de 10-20 mmTaiwán
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Helsinki University Central HospitalReclutamientoFractura del epicóndilo medial del húmero | Niños y Adolescentes de 7 a 16 años | Más de 2 mm de desplazamientoFinlandia
Ensayos clínicos sobre PET-enabled dual-energy CT imaging
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RenJi HospitalTerminadoSalida cardíacaPorcelana
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Fudan UniversityReclutamientoCáncer de mama metastásico (HER2 negativo)Porcelana
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Odense University HospitalTerminadoCáncer de Mama RecurrenteDinamarca
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Odense University HospitalTerminadoCancer de prostataDinamarca
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Luo YapingPeking Union Medical College HospitalAún no reclutandoTasa de filtración glomerular | Tomografía por emisión de positrones (PET) | Neoplasias Renales / CirugíaPorcelana
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Emory UniversityNational Cancer Institute (NCI)ReclutamientoNeoplasia neuroendocrina del sistema digestivo irresecable | Tumor neuroendocrino irresecable G1 del sistema digestivo | Tumor neuroendocrino del sistema digestivo | Sistema digestivo irresecable tumor neuroendocrino G2Estados Unidos