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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Tingfei Dr. Gu, M.D
- Telefonní číslo: 010-83572913
- E-mail: tingfei.gu@stx.ox.ac.uk
Studijní záloha kontaktů
- Jméno: Zhao Chen, M.D
- Telefonní číslo: 010-83572913
- E-mail: chenzhao0403@163.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína
- Peking University First Hospital
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Vrchní vyšetřovatel:
- Lei Kang, M.D, Ph.D
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Kontakt:
- Tingfei Dr. Gu, M.D
- Telefonní číslo: 010-83572913
- E-mail: tingfei.gu@stx.ox.ac.uk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Concordance Between Imaging Findings and Clinical Disease Assessment
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Lei Kang, M.D, Ph.D, Peking University First Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Novotvary
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Novotvary, plazmatické buňky
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Hemická a lymfatická onemocnění
- Mnohočetný myelom
Další identifikační čísla studie
- 2026R0036-0002
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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