NCT07319897
Not yet recruiting
Phase 2
A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET/CT for Targeting BCMA Expression in Multiple Myeloma.
Peking University First Hospital5 sites in 1 country300 target enrollmentStarted: December 25, 2025Last updated:
Interventions68Ga-BCMA PET/CT
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Diagnostic performance of 68Ga-BCMA PET/CT
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
68Ga-BCMA PET/CT
Experimental
Every patient will receive 68Ga-BCMA PET/CT
Intervention: 68Ga-BCMA PET/CT (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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