Multiple Myeloma (MM), Plasma Cell Disorders
Conditions
Keywords
targeted imaging, molecular imaging, GPRC5D, precise oncology, multiple myeloma, PET/CT, nuclear medicine, precise diagnosis
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGPRC5D-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.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Image interpretation will be performed independently by experienced nuclear medicine physicians who are blinded to participants' clinical data and to the findings of the comparator imaging studies (18F-FDG PET/CT and 68Ga-BCMA PET/CT) whenever feasible. Discordant findings will be resolved by consensus review.
Intervention model description
Single-arm imaging study in which each participant undergoes GPRC5D-targeted PET/CT, 18F-FDG PET/CT, and 68Ga-BCMA PET/CT for direct intra-patient comparison of lesion detection and disease assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Imaging Findings and Clinical Disease Assessment | 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. |
| Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT | 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. |
Countries
China
Contacts
CONTACTTingfei Dr. Gu, M.D
CONTACTZhao Chen, M.D
PRINCIPAL_INVESTIGATORLei Kang, M.D, Ph.D
Peking University First Hospital
Outcome results
None listed