RECRUITING Phase 1 ClinicalTrials.gov

GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders

Sponsor: Peking University First Hospital • ClinicalTrials.gov ID: NCT07660939

Registry updated: 2026-09-28

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Description

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.

Interventions

GPRC5D-Targeted PET/CT Imaging (Diagnostic test)
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.

Eligibility criteria

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.

Conditions

Plasma Cell Disorders Multiple Myeloma (MM)

Locations

Peking University First Hospital — Beijing, Beijing Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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