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Clinical PET Imaging Evaluation of 68Ga-NB381 Probe in Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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 PET/CT 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
TIANYAO Wang, PhD
tianyao.wang@pkufh.com
+8613439014669
Backup
Lei Kang, MD
kanglei@bjmu.edu.cn
+8613811486428
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Head to head PET imaging comparison between 18F-FDG and 68Ga-NB381 for MM diagnosis
1. 68Ga-NB381 PET/CT Examination: The patient will be intravenously injected with prepared and quality-controlled 68Ga-NB381 (0.05-0.1 mCi/kg). Two hours post-injection, a full-body scan will be conducted using the Shanghai United Imaging uMI 780 PET/CT, covering from the top of the head to the mid-thigh. If indeterminate lesions are identified in routine imaging, delayed imaging will be performed for further evaluation. The patient should lie in a supine position and breathe calmly. Data will be reconstructed using the OSEM method to obtain coronal, sagittal, and transverse PET and PET/CT fused images.~2. 18F-FDG PET/CT Examination: Patients must fast for more than 6 hours before the examination. 18F-FDG (0.05-0.1 mCi/kg) will be administered intravenously, and one hour later. Same requirement as mentioned above.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov