Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma
Conditions
Keywords
CD38, PET/CT, radiotracer, Multiple Myeloma
Brief summary
The objective of the study is to construct a noninvasive approach CD38 targeted PET/CT to detect tumor lesions in patients with Multiple Myeloma and to compare with FDG PET/CT.
Detailed description
CD38 targeting PET radiotracer is promising as an excellent imaging agent applicable to Multiple Myeloma. In this research, subjects with Multiple Myeloma or highly suspected recurrence detection underwent contemporaneous CD38 PET/CT and standard-of-care imaging (FDG PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and FDG PET/CT were recorded by visual interpretation. The diagnostic accuracy of CD38 PET/CT was calculated and compared to standard-of-care imaging.
Interventions
DIAGNOSTIC_TESTstandard-of-care imaging (FDG PET/CT), CD38 PET/CT
Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (FDG) and CD38, and undergoes PET/CT imaging within the specified time.
Sponsors
Guilin Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (aged 18 years or older); * Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of Multiple Myeloma (supporting evidence may include MRI, CT, tumor markers, and pathology report); * Patients who had scheduled both standard-of-care imaging (FDG PET/CT) and cd38 PET/CT scans; * Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion criteria
* The inability or unwillingness of the research participant or legal representative to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | 3 year | The sensitivity, specificity, and accuracy of standard-of-care imaging (FDG PET/CT) and CD38 PET/CT were calculated and compared to evaluate the diagnostic accuracy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions | 3 year | The numbers of positive primary and metastatic lesions of standard-of-care imaging (FDG PET/CT) and CD38 PET/CT were recorded by visual interpretation. |
| SUV | 3 year | Standardized uptake value (SUV) of standard-of-care imaging (FDG PET/CT) and CD38 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
Countries
China
Contacts
CONTACTXingyu Mu, M.D.
CONTACTWei Fu
Outcome results
None listed