New imaging method for diagnosing multiple myeloma
Clinical PET Imaging Evaluation of 68Ga-NB381 Probe in Multiple Myeloma
This study is testing a new imaging method to see if it can help doctors diagnose multiple myeloma earlier and more accurately than current methods.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06385652 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing a novel PET imaging probe, 68Ga-NB381, which targets the CD38 biomarker overexpressed in multiple myeloma (MM) cells. By enhancing the specificity and sensitivity of imaging, this approach aims to improve early diagnosis of MM, which is often missed due to reliance on invasive bone marrow biopsies. The study will involve comprehensive assessments, including patient selection and high-precision imaging, to evaluate the effectiveness of this new imaging agent in patients suspected of having MM.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 to 80 who are suspected of having multiple myeloma and are scheduled for a biopsy within the next three months.
Not a fit: Patients who are pregnant or unable to understand the examination process will not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging method could lead to earlier and more accurate diagnoses of multiple myeloma, improving patient outcomes.
How similar studies have performed: While the approach of using targeted nanobodies in imaging is promising, this specific application of 68Ga-NB381 in multiple myeloma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suspected of multiple myeloma who are scheduled to undergo bone marrow aspiration or tissue biopsy within the next 3 months; aged between 18 and 90 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures. * Confirmed symptomatic multiple myeloma patients; aged over 18 years; participants must fully understand and voluntarily participate in this study, and sign an informed consent form; must be able to independently comply with the examination procedures. Exclusion Criteria: * Pregnant women * Individuals who cannot understand the examination process or are unable to cooperate.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: TIANYAO Wang, PhD
- Email: tianyao.wang@pkufh.com
- Phone: +8613439014669
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.