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Clinical Trials in China / NCT07660939
Recruiting Phase 1

GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders

NCT07660939 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Phase 1
Started
2026-06-25
Last updated
2026-09-28

Condition(s) studied

Plasma Cell DisordersMultiple Myeloma (MM)

Investigational drug(s) / intervention(s)

GPRC5D-Targeted PET/CT Imaging

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions — 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.
  • Incidence and Severity of Adverse Events Following GPRC5D-Targeted Radiotracer Administration — 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.

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07660939 on ClinicalTrials.gov ↗ ← All trials in China