A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.

December 20, 2025 updated by: Peking University First Hospital
This is a prospective, multicenter, diagnostic imaging study designed to evaluate the diagnostic performance and clinical utility of BCMA-targeted Positron Emission Tomography/Computed Tomography (PET/CT) in patients with multiple myeloma and other palsma cell disorders. The study aims to non-invasively visualize and quantify the whole-body biodistribution of BCMA expression.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hebei
      • Beijingcun, Hebei, China
        • Beijing An Zhen Hospital of the Capital University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yini Wang, M.D, Ph.D
      • Beijingcun, Hebei, China
        • Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Lihong Li, M.D, Ph.D
      • Beijingcun, Hebei, China
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Lei Kang, M.D, Ph.D
        • Principal Investigator:
          • Yujun Dong, M.D, Ph.D
      • Shijiazhuang, Hebei, China
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Fuxu Wang, M.D, Ph.D
    • Jilin
      • Jilin, Jilin, China
        • First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Fengyan Jing, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(1) patients with suspected or previously diagnosed multiple myeloma (MM) who were scheduled for bone marrow aspiration or tissue biopsy within two weeks, including those undergoing initial diagnostic evaluation or follow-up/re-evaluation for disease monitoring or relapse; (2) patients with confirmed symptomatic MM; (3) ability to understand and voluntarily sign written informed consent; (4) ability to comply with study procedures; and (5) Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Exclusion Criteria:

pregnancy or lactation; inability to comprehend study procedures or cooperate with protocol requirements; or any other condition judged by the investigator to potentially interfere with study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-BCMA PET/CT
Every patient will receive 68Ga-BCMA PET/CT
Diagnostic test: 68Ga-BCMA PET/CT
Intravenous administration of the investigational BCMA-targeted radiopharmaceutical, followed by a whole-body PET/CT scan performed per a standardized protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of 68Ga-BCMA PET/CT
Time Frame: From enrollment to the end of PET/CT at 4 weeks
To determine the diagnostic accuracy of BCMA PET/CT for detecting active myeloma lesions, using biopsy confirmation as the reference standard.
From enrollment to the end of PET/CT at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

The Second Hospital of Hebei Medical University
Beijing Anzhen Hospital
The First Hospital of Jilin University
Beijing Tsinghua Changgeng Hospital

Investigators

  • Principal Investigator: Lei Kang, M.D, Ph.D, Peking University First Hospital
  • Principal Investigator: Yujun Dong, M.D, Ph.D, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFBC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The current approved protocol and informed consent forms do not include provisions for broad sharing of individual participant data with external researchers. The data generated are complex, integrating sensitive clinical information with novel imaging biomarkers, and require significant resources to prepare for responsible sharing. Data may be available for collaborative research upon reasonable request to the Principal Investigator, subject to execution of appropriate data transfer and use agreements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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