GPRC5D-targeted PET/CT imaging in plasma cell disorders
Official title: A Single-Center, Phase I, Single-Arm Prospective Interventional Study of GPRC5D-Targeted PET/CT Imaging in Patients With Multiple Myeloma and Other Plasma Cell Disorders
Run by Peking University First Hospital · NCT07660939 · Data updated 2026-11-12
This study tests a new GPRC5D-targeted PET/CT imaging method in adults with plasma cell disorders to see if it detects disease better or differently than standard imaging.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | May 25, 2027 |
| Study ends | May 25, 2027 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07660939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed or suspected plasma cell disorders, including multiple myeloma, who can undergo PET/CT imaging and provide informed consent.
✕Probably not a fit
Patients with lesions not detectable by GPRC5D-targeted imaging or with contraindications to PET/CT may not receive added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, single-center, single-arm Phase 1 imaging study evaluating the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET/CT in patients with plasma cell disorders, including multiple myeloma. Participants will receive GPRC5D-targeted PET/CT, plus 18F-FDG PET/CT and 68Ga-BCMA PET/CT, ideally within five days for direct head-to-head comparison. The goal is to determine how well GPRC5D-targeted imaging detects lesions and assesses disease status compared with current molecular imaging modalities. GPRC5D is selected because it is highly expressed on malignant plasma cells and shows limited normal tissue expression, which may improve disease detection and characterization. Safety, biodistribution, and diagnostic performance will be the primary endpoints, with secondary observations on potential clinical utility in disease evaluation and treatment planning.
Why it matters
Potential benefit: If successful, patients could benefit from more accurate detection and monitoring of plasma cell disorders using a novel imaging approach.
How similar studies have gone: Prior imaging approaches targeting alternative antigens have shown promise, but GPRC5D-directed imaging is a novel approach with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Lei Kang, M.D, Ph.D — Peking University First Hospital
- Study coordinator: Tingfei Dr. Gu, M.D
- Email: tingfei.gu@stx.ox.ac.uk
- Phone: 010-83572913
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.