GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders
A Single-Center, Phase I, Single-Arm Prospective Interventional Study of GPRC5D-Targeted PET/CT Imaging in Patients With Multiple Myeloma and Other Plasma Cell Disorders
This is a prospective, single-center, single-arm Phase I study evaluating GPRC5D-targeted PET/CT imaging in patients with plasma cell disorders, including multiple myeloma.
Participants will undergo GPRC5D-targeted PET/CT, 18F-FDG PET/CT, and 68Ga-BCMA PET/CT within 5 days whenever feasible for head-to-head comparison of lesion detection and disease assessment.
The study aims to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET/CT and to compare its imaging characteristics with currently available molecular imaging modalities in plasma cell disorders.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center, single-arm Phase I interventional imaging study designed to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET/CT imaging in patients with plasma cell disorders, including multiple myeloma.
GPRC5D is a novel therapeutic and molecular imaging target that is highly expressed on malignant plasma cells while showing limited expression in normal tissues. Recent advances in GPRC5D-targeted immunotherapies have demonstrated promising clinical activity in multiple myeloma, highlighting the potential value of GPRC5D-directed molecular imaging for disease detection, tumor burden evaluation, treatment selection, therapeutic response assessment and prognostic evaluation.
Current standard molecular imaging with 18F-FDG PET/CT has several limitations in multiple myeloma, including reduced sensitivity in lesions with low hexokinase-2 expression and limited specificity due to inflammatory uptake.Therefore, development of novel imaging approaches targeting alternative plasma cell antigens may improve disease evaluation and provide complementary biological information.
In this study, eligible participants will undergo GPRC5D-targeted PET/CT imaging together with standard molecular imaging examinations, including 18F-FDG PET/CT and 68Ga-BCMA PET/CT. Whenever feasible, all imaging studies will be completed within 5 days to minimize interval changes in disease status and enable direct head-to-head comparison among imaging modalities.
Imaging findings from GPRC5D-targeted PET/CT will be compared with 18F-FDG PET/CT and 68Ga-BCMA PET/CT with respect to lesion detectability, disease distribution, tumor uptake characteristics, and overall disease assessment. The study will also evaluate tracer biodistribution, radiation dosimetry, image quality, and safety of the GPRC5D-targeted radiotracer.
The results of this study may help establish GPRC5D-targeted PET/CT as a novel molecular imaging tool for plasma cell disorders and support future development of GPRC5D-directed theranostic strategies in multiple myeloma.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tingfei Dr. Gu, M.D
- Número de teléfono: 010-83572913
- Correo electrónico: tingfei.gu@stx.ox.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Zhao Chen, M.D
- Número de teléfono: 010-83572913
- Correo electrónico: chenzhao0403@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana
- Peking University First Hospital
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Investigador principal:
- Lei Kang, M.D, Ph.D
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Contacto:
- Tingfei Dr. Gu, M.D
- Número de teléfono: 010-83572913
- Correo electrónico: tingfei.gu@stx.ox.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults with confirmed or suspected plasma cell disorders, including multiple myeloma.
- Healthy volunteers eligible for PET/CT imaging may also be enrolled.
- Availability of recent clinical laboratory results within 1 week prior to imaging, when applicable.
- Ability to undergo PET/CT imaging procedures.
- Ability to understand the study requirements and provide written informed consent.
Exclusion Criteria:
- History of other active malignant tumors, unless considered clinically insignificant by the investigator.
- Pregnant or breastfeeding women.
- Inability to understand study procedures or comply with imaging examinations.
- Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or image interpretation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: GPRC5D PET/CT Imaging With Comparator PET/CT Studies
Participants with plasma cell disorders, including multiple myeloma, will undergo GPRC5D-targeted PET/CT imaging following intravenous administration of the investigational GPRC5D-targeted radiotracer.
Participants will also undergo 18F-FDG PET/CT and 68Ga-BCMA PET/CT within 5 days whenever feasible for intra-individual head-to-head comparison of lesion detection and disease assessment.
Safety, biodistribution, tracer uptake characteristics, and imaging performance will be evaluated.
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Participants with plasma cell disorders, including multiple myeloma, will undergo GPRC5D-targeted PET/CT imaging following intravenous administration of the investigational GPRC5D-targeted radiotracer.
Participants will also undergo 18F-FDG PET/CT and 68Ga-BCMA PET/CT within 5 days whenever feasible for intra-individual head-to-head comparison of lesion detection and disease assessment.
Safety, biodistribution, tracer uptake characteristics, and imaging performance will be evaluated.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions
Periodo de tiempo: Within 5 days after completion of all PET/CT imaging examinations
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Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and inter-reader agreement between independent readers for identification of disease lesions in participants with plasma cell disorders, compared with standard reference assessments and with 18F-FDG PET/CT and 68Ga-BCMA PET/CT.
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Within 5 days after completion of all PET/CT imaging examinations
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Incidence and Severity of Adverse Events Following GPRC5D-Targeted Radiotracer Administration
Periodo de tiempo: From radiotracer administration to 30 days after PET/CT imaging
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Number of participants experiencing adverse events and severity of adverse events following administration of the GPRC5D-targeted radiotracer, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
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From radiotracer administration to 30 days after PET/CT imaging
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Concordance Between Imaging Findings and Clinical Disease Assessment
Periodo de tiempo: From imaging to 1 months of clinical follow-up
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Concordance between GPRC5D-targeted PET/CT findings and clinical, laboratory, and conventional imaging assessments of disease status.
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From imaging to 1 months of clinical follow-up
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Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT
Periodo de tiempo: At the time of image interpretation within 5 days after imaging
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Tumor-to-background ratio (TBR), maximum standardized uptake value (SUVmax), and mean standardized uptake value (SUVmean) of disease lesions identified on GPRC5D-targeted PET/CT.
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At the time of image interpretation within 5 days after imaging
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lei Kang, M.D, Ph.D, Peking University First Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Gu T, Chen Z, Kang L. New Retroperitoneal Soft-Tissue Lesion in Multiple Myeloma. JAMA Oncol. 2026 Apr 1;12(4):413-414. doi: 10.1001/jamaoncol.2025.6443.
- Gu T, Chen Z, Wang T, Dong Y, Kang L. B-cell maturation antigen targeted PET/CT imaging in multiple myeloma: a first-in-human study. J Hematol Oncol. 2025 Nov 14;18(1):101. doi: 10.1186/s13045-025-01758-3.
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
- 2026R0036-0002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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