RecruitingEarly Phase 1NCT06717113

A Molecular Probe Targeting BCMA for the Clinical Diagnosis of Multiple Myeloma

Clinical PET Imaging Evaluation of 68Ga-BC1 Probe in Multiple Myeloma

Sponsor

Peking University First Hospital

Enrollment

50 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms

Summary

Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. However, traditional full-length antibody probes suffer from delayed tumor uptake peaks and low target-to-background ratios, limiting their clinical utility. In our study, a peptide or nanobody targeting BCMA was developed by computer-aided designing, which was subsequently radiolabeled with 68Ga to create a novel molecular probe, 68Ga-MM-BC1. This research aims to overcome the diagnostic limitations of MM and may also offer valuable insights for molecular-targeted imaging in other malignant tumors.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a molecular imaging probe that targets a protein called BCMA, which is found on multiple myeloma cells (a type of blood cancer). The goal is to use this probe as a diagnostic tool to detect and monitor multiple myeloma more precisely using PET scans. **You may be eligible if...** - You are suspected to have multiple myeloma and are scheduled for a bone marrow biopsy within the past 3 months, OR - You have already been diagnosed with symptomatic multiple myeloma - You can understand and cooperate with the examination - You have signed informed consent **You may NOT be eligible if...** - You are pregnant - You are unable to understand or cooperate with the examination process Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-FDG

Prior to the examination, patients will be required to fast for at least 6 hours. 18F-FDG (0.05-0.1 mCi/kg) will be intravenously injected, and one hour after the injection, head and torso imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the upper third of the thigh. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

DRUG68Ga-BC1

The prepared and quality-controlled 68Ga-BC1 (0.05-0.1 mCi/kg) will be intravenously injected into the patient. Two hours after the injection, whole-body imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the mid-thigh. If any indeterminate lesions are found during the routine imaging, delayed imaging will be performed for further differentiation. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

Locations(2)

Department of Nuclear Medicine, Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT06717113