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Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors

NCT07459192 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-09

No results posted yet for this study

Summary

Immune checkpoint blockade (ICB) therapy has become a milestone breakthrough in oncology by activating the host immune system to recognize and eliminate tumor cells . Among these, programmed death protein 1 (PD-1) and its ligand (PD-L1) are currently the most widely used targets in clinical practice . However, clinical data indicate that only a subset of patients benefit from anti-PD-1/PD-L1 therapy. Due to the heterogeneity of the tumor microenvironment and the spatiotemporal dynamic changes in PD-L1 expression, traditional tissue biopsy-based detection methods often fail to comprehensively assess disease status, leading to limited treatment response rates . Therefore, there is an urgent need to develop precise strategies for non-invasive, real-time, and dynamic evaluation of PD-L1 expression and treatment response.

Nuclear medicine molecular imaging techniques, particularly positron emission tomography (PET), provide a critical means for non-invasive in vivo visualization of tumor biomarkers . Given the pivotal role of PD-L1 in tumor immune evasion, real-time monitoring of its expression levels is of significant importance for the precise guidance of immunotherapy. In recent years, radiotracer agents based on peptides and small molecules have garnered considerable attention due to their advantages in tissue penetration, rapid blood clearance, and high signal-to-noise ratio imaging. Various PD-L1 probes (e.g., \[¹⁸F\]BMS-986229, \[¹⁸F\]AlF-NOTA-IMB) have demonstrated promising application potential in preclinical or clinical studies . Meanwhile, although PD-1/PD-L1 monoclonal antibodies such as nivolumab and atezolizumab have significantly improved treatment outcomes for multiple tumors , they still exhibit inherent limitations in tissue penetration, in vivo clearance rate, imaging background, immunogenicity, and cost. Additionally, PD-L1-targeted therapies alone show limited efficacy in some patients, prompting researchers to further explore novel mechanisms such as protein degradation targeting (PROTAC) to achieve more comprehensive regulation of PD-L1.

Conditions

  • Canser

Sponsors & Collaborators

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-30
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT07459192 on ClinicalTrials.gov