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Recruiting
NCT07660939
GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders
Conditions: Plasma Cell Disorders, Multiple Myeloma (MM)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 50
Sponsor: Peking University First Hospital
Location: Peking University First Hospital Beijing Beijing Municipality
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 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.
Source: ClinicalTrials.gov (NCT07660939). StuddyBuddy aggregates publicly available trial information.