ClinicalTrials.gg
RecruitingNCT07660939Updated Sep 28, 2026

GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders

A Phase 1 interventional study of GPRC5D-Targeted PET/CT Imaging in Plasma Cell Disorders and Multiple Myeloma (MM), sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Peking University First Hospital · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Sep 28, 2026Now RecruitingSite recruiting status changedGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 448 studies in Multiple Myeloma with a site in China — 238 open to participants now, 275 under way, 47 of them phase 3. Multiple Myeloma · China.

Planned enrollment
176th of 406
50 · median 40
Started
2026
with 53 others
Phase 1
151 of 448
73 open now
Primary completion
2027-05
later than 141 of 274 live
Registered
426th of 448
by date

Among the 448 studies in Multiple Myeloma with a site in China, this one is the 176th largest by planned enrollment of the 406 interventional ones that give a count, is one of 54 that started in 2026, is one of 151 in phase 1, reaches primary completion later than 141 of the 274 other live ones, and was the 426th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

238 of the 448 studies in Multiple Myeloma with a site in China are open now. Recruiting first, the newest first:

232 more — sign in →

All 238 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 448 studies in Multiple Myeloma with a site in China, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Plasma Cell Disorders
  • Multiple Myeloma (MM)

Browse trials for

Keywords

  • targeted imaging
  • molecular imaging
  • GPRC5D
  • precise oncology
  • multiple myeloma
  • PET/CT
  • nuclear medicine
  • precise diagnosis
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    GPRC5D PET/CT Imaging With Comparator PET/CT Studies

    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

  • 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.

06

What researchers measure

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 examinations

  2. 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 imaging

Secondary 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-up

  2. 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 imaging

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 41678152 ↗
  • 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. PubMed 41239440 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.

Of 201 non-industry phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's planned 11 months is below that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 22, 2026
StartActual
Jun 25, 2026
Primary completionEst.
May 25, 2027
CompletionEst.
May 25, 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
Peking University First Hospital is now Recruiting
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    Peking University First Hospital is now Recruiting
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07660939
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Jun 25, 2026
Primary completion
May 25, 2027 (estimated)
Completion
May 25, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Tingfei Dr. Gu, M.D
Contact
tingfei.gu@stx.ox.ac.uk
010-83572913
Zhao Chen, M.D
Contact
chenzhao0403@163.com
010-83572913
Lei Kang, M.D, Ph.D
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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