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GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders

16. juni 2026 oppdatert av: Peking University First Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Peking University First Hospital
        • Hovedetterforsker:
          • Lei Kang, M.D, Ph.D
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Diagnostisk test: GPRC5D-Targeted PET/CT Imaging
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions
Tidsramme: Within 5 days after completion of all PET/CT imaging examinations
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.
Within 5 days after completion of all PET/CT imaging examinations
Incidence and Severity of Adverse Events Following GPRC5D-Targeted Radiotracer Administration
Tidsramme: From radiotracer administration to 30 days after PET/CT imaging
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.
From radiotracer administration to 30 days after PET/CT imaging

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concordance Between Imaging Findings and Clinical Disease Assessment
Tidsramme: From imaging to 1 months of clinical follow-up
Concordance between GPRC5D-targeted PET/CT findings and clinical, laboratory, and conventional imaging assessments of disease status.
From imaging to 1 months of clinical follow-up
Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT
Tidsramme: At the time of image interpretation within 5 days after imaging
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.
At the time of image interpretation within 5 days after imaging

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University First Hospital

Etterforskere

  • Hovedetterforsker: Lei Kang, M.D, Ph.D, Peking University First Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. juni 2026

Primær fullføring (Antatt)

25. mai 2027

Studiet fullført (Antatt)

25. mai 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026R0036-0002

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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