Clinical trial · Interventional
Application Study of 68Ga-NOTA-BCMA Nanoantibody Imaging in Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study intends to employ 68Ga-NOTA-BCMA nanobody PET/CT imaging in patients with multiple myeloma to evaluate the feasibility of this technique for myeloma assessment, analyze the correlation between 68Ga-NOTA-BCMA nanobody uptake intensity and disease staging, tumor burden, and prognosis, explore its value in assessing treatment response and predicting early relapse, and compare its detection rate for myeloma lesions with that of 18F-FDG PET/CT. The results of this study may provide a more sensitive and specific imaging diagnostic method for patients with multiple myeloma and offer a basis for the individualized selection of future BCMA-targeted therapies. This study has been approved by the Ethics Committee of Peking Union Medical College Hospital.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-BCMA nanobody PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCMA and FDG
- description
- All enrolled patients will undergo both 68Ga-BCMA nanobody PET/CT imaging and 18F-FDG PET/CT imaging.On the day of the examination (fasting is not required), an intravenous injection of the 68Ga-NOTA-BCMA nanobody will be administered, followed by PET/CT imaging approximately 0.5 to 1 hour later. Within 1 to 2 weeks, 18F-FDG PET/CT imaging will be performed, which requires an intravenous injection of 18F-FDG (fasting for at least 4 hours is required) followed by PET/CT imaging approximately 1 hour later.
- interventionNames
- Diagnostic Test: 68Ga-BCMA nanobody PET/CT
- Diagnostic Test: 18F-FDG PET/CT
Primary outcomes (1)
- measure
- Detection rate of 68Ga-BCMA nanobody PET/CT
- timeFrame
- through study completion, an average of 1 year
- description
- The number of patients with positive BCMA PET results was counted and divided by the total number of individuals who completed BCMA PET imaging to calculate the detection rate of BCMA PET.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed or relapsed MM patients * Written informed consent obtained and capable of undergoing follow-up. Exclusion Criteria: * Severely abnormal liver and kidney function * Women who are planning pregnancy, are pregnant, or are breastfeeding, as well as those with childcare plans during the study period; subjects of childbearing potential must use effective contraceptive measures throughout the study. * Individuals unable to lie flat for 30 minutes. * Individuals who decline to participate in this clinical study. * Patients with claustrophobia or other psychiatric disorders, or poor compliance that may compromise their ability to cooperate with the study procedures. * Other circumstances deemed by the investigator as unsuitable for participation in this clinical trial.
References
Publications (0)
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