Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 10:22 AM
Study NCT ID:
NCT07459192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'histopathological findings obtained from biopsy or resected surgical specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic efficacy, survival analysis', 'timeFrame': 'Completed within half year after end of the study', 'description': 'sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['canser', 'PET', 'DOTA-BLP', 'PD-L1'], 'conditions': ['Canser']}, 'descriptionModule': {'briefSummary': '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.\n\nNuclear 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.', 'detailedDescription': '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.\n\nNuclear 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 .\n\nCurrently, PROTAC molecular drugs targeting the degradation of disease-related proteins have achieved significant progress in multiple targets, such as Bruton\'s tyrosine kinase (BTK), androgen receptor (AR), and estrogen receptor (ER) . These molecules achieve efficient regulation of pathogenic protein levels by precisely identifying target proteins and recruiting E3 ubiquitin ligases to initiate ubiquitin-proteasome system-mediated degradation of target proteins. However, existing PROTAC research primarily focuses on therapeutic functions, with in vivo distribution, targeting specificity, and efficacy evaluation still heavily dependent on indirect methods, which limits their clinical translation. Therefore, developing a strategy that can simultaneously achieve "precision molecular imaging" and "targeted therapy" on a single molecular platform holds significant research value. If PET imaging, targeted protein degradation, and radioleukotriene therapy (RLT) are organically integrated into a single molecular system, it would not only enable real-time, quantitative visual monitoring of target expression and drug action processes but also facilitate precision radiotherapy based on this integration. This approach could overcome the limitations of traditional antibody drugs in tissue penetration, imaging-therapeutic synergy, and efficacy prediction, providing a novel molecular design paradigm for precision oncology diagnosis and treatment.\n\nBased on this, the present study designed and constructed a novel multifunctional molecular DOTA-BLP and its radiolabeled derivative ⁶⁸Ga-DOTA-BLP, aiming to achieve dynamic monitoring of PD-L1 using PET imaging. Systematic evaluation in MC38 tumor-bearing mouse models demonstrated that this probe exhibits excellent pharmacokinetic properties and specific imaging capabilities, providing a highly promising solution to address the bottleneck issues in PD-L1-targeted therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with malignant tumors confirmed by biopsy or surgical pathology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years, gender not restricted;\n* patients with malignant tumors confirmed by biopsy or surgical pathology;\n* Imaging findings of suspicious lymph nodes or distant metastases;\n* informed consent signed in writing by the subject or his/her legal guardian.\n\nExclusion Criteria:\n\n* patients who have received antitumor therapy prior to PET/CT or PET/MR scanning;\n* Patients with severe medical conditions who cannot tolerate PET/CT or PET/MR scans;\n* The alternative subjects have contraindications to PET/CT or PET/MR scans;\n* exposure to radiation of more than 50 mSv in the past year;\n* 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;\n* The alternative subjects had any clinical conditions that the principal investigator of this study considered to be potentially harmful or associated with the formulation.'}, 'identificationModule': {'nctId': 'NCT07459192', 'briefTitle': 'Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'Clinical Study of 68Ga-DOTA-BLP PET Imaging in Noninvasive Diagnosis of Malignant Tumors', 'orgStudyIdInfo': {'id': '2026009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DOTA-BLP PET', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chognqing', 'country': 'China', 'facility': 'Daping Hospital, Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'xiao chen, PH.D', 'role': 'CONTACT', 'email': 'xiaochen229@tmmu.edu.cn', 'phone': '15922970174'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nuclear Medicine Department', 'investigatorFullName': 'Xiao Chen', 'investigatorAffiliation': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}}}}