NCT07660939

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026May 2027

First Submitted

Initial submission to the registry

June 8, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 25, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2027

Last Updated

June 22, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

June 8, 2026

Last Update Submit

June 16, 2026

Conditions

Plasma Cell DisordersMultiple Myeloma (MM)

Keywords

targeted imagingmolecular imagingGPRC5Dprecise oncologymultiple myelomaPET/CTnuclear medicineprecise diagnosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    Within 5 days after completion of all PET/CT imaging examinations

  • 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.

    From radiotracer administration to 30 days after PET/CT imaging

Secondary Outcomes (2)

  • Concordance Between Imaging Findings and Clinical Disease Assessment

    From imaging to 1 months of clinical follow-up

  • Tumor-to-Background Ratio on GPRC5D-Targeted PET/CT

    At the time of image interpretation within 5 days after imaging

Study Arms (1)

GPRC5D PET/CT Imaging With Comparator PET/CT Studies

EXPERIMENTAL

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.

Diagnostic Test: GPRC5D-Targeted PET/CT Imaging

Interventions

GPRC5D-Targeted PET/CT ImagingDIAGNOSTIC_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.

GPRC5D PET/CT Imaging With Comparator PET/CT Studies

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (2)

  • Gu T, Chen Z, Kang L. New Retroperitoneal Soft-Tissue Lesion in Multiple Myeloma. JAMA Oncol. 2026 Apr 1;12(4):413-414. doi: 10.1001/jamaoncol.2025.6443.

    PMID: 41678152BACKGROUND

  • Gu T, Chen Z, Wang T, Dong Y, Kang L. B-cell maturation antigen targeted PET/CT imaging in multiple myeloma: a first-in-human study. J Hematol Oncol. 2025 Nov 14;18(1):101. doi: 10.1186/s13045-025-01758-3.

    PMID: 41239440BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Lei Kang, M.D, Ph.D

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingfei Dr. Gu, M.D

CONTACT

010-83572913tingfei.gu@stx.ox.ac.uk

Zhao Chen, M.D

CONTACT

010-83572913chenzhao0403@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 22, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

May 25, 2027

Study Completion (Estimated)

May 25, 2027

Last Updated

June 22, 2026

Record last verified: 2026-05

Locations

CN(1)