Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385652
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
PET Imaging Study of 68Ga-NB381 in Multiple Myeloma
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Clinical PET Imaging Evaluation of 68Ga-NB381 Probe in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple myeloma MM predominantly affects the elderly often presenting insidiously and with a rising incidence rate Current diagnostic methods primarily rely on invasive bone marrow biopsies which can lead to false-negative results if the biopsy site is improperly chosen CD38 is significantly overexpressed on the surface of malignant plasma cells in MM making it a characteristic tumor biomarker for this disease
Addressing the limitations in specificity and sensitivity of traditional PET imaging agents this project is dedicated to developing a new type of nanobody PETCT imaging probe 68Ga-NB381 which possesses high affinity and targets CD38 This probe which is an intellectual property of our institution aims to enhance the accuracy and specificity of early MM diagnosis In terms of clinical evaluation the project will implement a comprehensive assessment process including case selection collection of baseline information high-precision imaging expert-level image interpretation and follow-up studies comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381 This lays the groundwork for the clinical translation of this radiopharmaceutical in China Furthermore the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab a drug also targeting CD38 This makes the project of significant academic value and clinical importance thus promoting the development of personalized treatment strategies
Addressing the limitations in specificity and sensitivity of traditional PET imaging agents this project is dedicated to developing a new type of nanobody PETCT imaging probe 68Ga-NB381 which possesses high affinity and targets CD38 This probe which is an intellectual property of our institution aims to enhance the accuracy and specificity of early MM diagnosis In terms of clinical evaluation the project will implement a comprehensive assessment process including case selection collection of baseline information high-precision imaging expert-level image interpretation and follow-up studies comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381 This lays the groundwork for the clinical translation of this radiopharmaceutical in China Furthermore the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab a drug also targeting CD38 This makes the project of significant academic value and clinical importance thus promoting the development of personalized treatment strategies
Detailed Description:
Multiple myeloma MM commonly occurs in the elderly and often remains undetected until it reaches an advanced stage With the aging population in China the incidence of MM is on the rise now surpassing that of acute leukemia Clinically MM is characterized by bone destruction and lacks specificity diagnosis primarily relies on bone marrow biopsies that detect an increase in clonal plasma cells which are invasive and can yield false-negative results if the biopsy site is improperly selected CD38 is significantly overexpressed on the surface of malignant plasma cells in MM making it a characteristic tumor biomarker for MM
As the incidence of malignant tumors in China continues to increase so does the clinical demand for radiopharmaceuticals Addressing the limitations in the targeting of 18F-FDG in PET imaging the development of new targeted nuclear medicine molecular probes is of significant academic value and clinical importance particularly in monitoring the therapeutic effects of the CD38-targeted nanobody NB381 which offers unique advantages This project uses a nanobody with high affinity for CD38 as the targeting moiety for the radiopharmaceutical exploring the diagnostic efficiency of 68Ga-NB381 in patients with MM exhibiting high CD38 expression This not only provides a basis for the early diagnosis of MM but also allows for the formulation of effective precision treatment strategies based on the CD38 expression profile in MM patients
68Ga-NB381 a new CD38-targeted molecular probe labeled with 68Ga can be used for the diagnosis and research of various malignancies expressing high levels of CD38 including MM The probe is conjugated with 68Ga3 using TOHP as a bifunctional chelator with a simple labeling process that does not require purification offering high in-vivo stability and significant radioactive accumulation in tumor sites in mouse models resulting in superior imaging outcomes This project will complete the automation of the 68Ga-NB381 labeling process and conduct quality control studies on the resulting radiopharmaceutical injection solution establishing quality standards for this new PET probe and laying the foundation for its clinical translation in China The project aims to provide 68Ga-NB381 PETCT imaging studies to support the early diagnosis of CD38 high-expression malignancies the formulation of treatment plans and the assessment of therapeutic efficacy
As the incidence of malignant tumors in China continues to increase so does the clinical demand for radiopharmaceuticals Addressing the limitations in the targeting of 18F-FDG in PET imaging the development of new targeted nuclear medicine molecular probes is of significant academic value and clinical importance particularly in monitoring the therapeutic effects of the CD38-targeted nanobody NB381 which offers unique advantages This project uses a nanobody with high affinity for CD38 as the targeting moiety for the radiopharmaceutical exploring the diagnostic efficiency of 68Ga-NB381 in patients with MM exhibiting high CD38 expression This not only provides a basis for the early diagnosis of MM but also allows for the formulation of effective precision treatment strategies based on the CD38 expression profile in MM patients
68Ga-NB381 a new CD38-targeted molecular probe labeled with 68Ga can be used for the diagnosis and research of various malignancies expressing high levels of CD38 including MM The probe is conjugated with 68Ga3 using TOHP as a bifunctional chelator with a simple labeling process that does not require purification offering high in-vivo stability and significant radioactive accumulation in tumor sites in mouse models resulting in superior imaging outcomes This project will complete the automation of the 68Ga-NB381 labeling process and conduct quality control studies on the resulting radiopharmaceutical injection solution establishing quality standards for this new PET probe and laying the foundation for its clinical translation in China The project aims to provide 68Ga-NB381 PETCT imaging studies to support the early diagnosis of CD38 high-expression malignancies the formulation of treatment plans and the assessment of therapeutic efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None