GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University First Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
GPRC5D-Targeted PET/CT Imaging
Diagnostic testParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: GPRC5D PET/CT Imaging With Comparator PET/CT StudiesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of GPRC5D-Targeted PET/CT for Detection of Disease Lesions
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.
Time frame
Within 5 days after completion of all PET/CT imaging examinations2
Incidence and Severity of Adverse Events Following GPRC5D-Targeted Radiotracer Administration
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.
Time frame
From radiotracer administration to 30 days after PET/CT imagingSecondary outcomes
1
Concordance Between Imaging Findings and Clinical Disease Assessment
Concordance between GPRC5D-targeted PET/CT findings and clinical, laboratory, and conventional imaging assessments of disease status.
Time frame
From imaging to 1 months of clinical follow-up2
Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT
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.
Time frame
At the time of image interpretation within 5 days after imagingSponsors and contacts
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Source ClinicalTrials.gov