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

NCT07459192 | Not Yet Recruiting

• 1 other identifier: 2026009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

canser; PET; DOTA-BLP; PD-L1

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy, survival analysis

  sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

  Completed within half year after end of the study

Study Arms (1)

DOTA-BLP PET

To address the limitations of current PD-L1 probes with low uptake and rapid clearance in lesions, this study aims to validate the high uptake and prolonged retention characteristics of DOTA-BLP at lesion sites. This approach seeks to overcome the technical bottlenecks of weak imaging signals and short window periods in existing technologies, thereby enhancing the detection efficiency of PD-L1-positive lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with malignant tumors confirmed by biopsy or surgical pathology.

You may qualify if:

• Age over 18 years, gender not restricted;
• patients with malignant tumors confirmed by biopsy or surgical pathology;
• Imaging findings of suspicious lymph nodes or distant metastases;
• informed consent signed in writing by the subject or his/her legal guardian.

You may not qualify if:

• patients who have received antitumor therapy prior to PET/CT or PET/MR scanning;
• Patients with severe medical conditions who cannot tolerate PET/CT or PET/MR scans;
• The alternative subjects have contraindications to PET/CT or PET/MR scans;
• exposure to radiation of more than 50 mSv in the past year;
• The alternative subjects underwent major surgery within the past 3 months; received experimental drug or device therapy (with unclear efficacy or safety) within the past 1 month;
• The alternative subjects had any clinical conditions that the principal investigator of this study considered to be potentially harmful or associated with the formulation.

Sponsors & Collaborators

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

Study Sites (1)

Daping Hospital, Army Medical University

Chongqing, Chognqing, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

Central Study Contacts

xiao chen, PH.D

CONTACT

15922970174; xiaochen229@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)