BCMA-targeted PET imaging probe for diagnosing multiple myeloma.
Clinical PET Imaging Evaluation of 68Ga-BC1 Probe in Multiple Myeloma
We will test a new 68Ga-labeled BCMA-targeted PET probe (68Ga-MM-BC1) to see if it detects multiple myeloma more accurately in people suspected of or diagnosed with the disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06717113 on ClinicalTrials.gov |
What this trial studies
This early-phase study uses a small peptide or nanobody that binds BCMA, radiolabeled with gallium-68 (68Ga-MM-BC1), to perform immuno-PET imaging in patients with suspected or confirmed multiple myeloma. The approach aims to overcome limitations of full-length antibody probes by producing faster tumor uptake and higher target-to-background ratios. Participants will undergo 68Ga-MM-BC1 imaging, with standard 18F-FDG PET as a comparator when applicable, and imaging findings will be correlated with recent bone marrow or tissue biopsy results. The trial focuses on diagnostic performance and feasibility in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults suspected of multiple myeloma who have had or are scheduled for bone marrow aspiration or tissue biopsy within three months, or adults with symptomatic, diagnosed multiple myeloma who can provide informed consent and tolerate PET imaging.
Not a fit: Pregnant individuals, people unable to understand or cooperate with the imaging process, and patients whose tumors express very low BCMA are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the probe could improve detection of myeloma lesions, reduce false-negative biopsies, and help guide more precise treatment decisions.
How similar studies have performed: Preclinical and some early human immuno-PET work targeting BCMA and using small probes like nanobodies has shown promise, but 68Ga-MM-BC1 is a novel early-phase clinical test.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspected multiple myeloma patients scheduled for bone marrow aspiration or tissue biopsy within the past 3 months; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination. * Diagnosed symptomatic multiple myeloma patients; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination. Exclusion Criteria: * Pregnant women; individuals unable to understand the examination process or who are unable to cooperate.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Department of Nuclear Medicine, Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University First Hospital — Beijing, Beijing Municipality, China (Enrolling_by_invitation)
Study contacts
- Principal investigator: Tianyao Wang, Ph.D. — Peking University First Hospital
- Study coordinator: Tianyao Wang, PhD
- Email: tianyao.wang@pkufh.com
- Phone: 9298551137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.