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A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma

NCT06925958 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-13

No results posted yet for this study

Summary

Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. CD38, which is abnormally elevated in 95% to 100% of malignant plasma cells but relatively low in normal cells, serves as a biomarker for multiple myeloma. In clinical practice, CD38 expression is typically detected through flow cytometry and microscopic examination of bone marrow biopsy samples. However, biopsies are invasive and prone to false-negative results in cases of heterogeneity or small lesion samples, whereas whole-body imaging methods allow non-invasive assessment of target expression.

\[¹⁸F\]FDG PET/CT imaging is one of the most commonly used techniques in multiple myeloma. However, its diagnostic application is limited by false-negative results due to low hexokinase 2 expression in myeloma cells. Additionally, it fails to provide accurate molecular information, such as CD38 expression in cells. Therefore, this study aims to develop a more specific and stable molecular imaging probe, ⁶⁸Ga-NOTA-SCH001, to non-invasively visualize CD38 expression and monitor responses to CD38-targeted therapy in real time. This approach may also contribute to the formulation and optimization of clinical treatment strategies.

Conditions

  • Multiple Myeloma (MM)

Interventions

DIAGNOSTIC_TEST

Flow cytometry

CD38 Flow cytometry testing

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06925958 on ClinicalTrials.gov